Discover Career Opportunities in Pharmacovigilance and Drug Safety

What do pharmacovigilance and drug safety do?

Pharmacovigilance and drug safety experts play a crucial role in monitoring and evaluating the safety of pharmaceutical products. They collect and analyze data on adverse drug reactions, assess the risks and benefits of medications, and ensure compliance with regulatory requirements. This work helps safeguard public health by identifying and mitigating potential risks associated with medications.

What are the duties associated with the roles of pharmacovigilance and drug safety professionals?

Duties associated with the roles of pharmacovigilance and drug safety professionals include:

  1. Adverse Event Monitoring: Collecting, reviewing, and evaluating reports of adverse drug reactions (ADRs) from healthcare professionals and patients.
  2. Signal Detection: Identifying potential safety concerns or emerging trends related to specific drugs or drug classes.
  3. Risk Assessment: Assessing the risks and benefits of pharmaceutical products, including conducting benefit-risk assessments.
  4. Regulatory Reporting: Preparing and submitting regulatory reports of adverse events to health authorities, ensuring compliance with regulatory requirements.
  5. Safety Database Management: Maintaining and updating safety databases to track and document adverse events.
  6. Clinical Trial Safety: Monitoring the safety of participants in clinical trials and ensuring protocol compliance.
  7. Safety Labeling: Collaborating with regulatory affairs teams to update drug labeling with safety information.
  8. Risk Minimization: Developing and implementing risk minimization strategies, such as Risk Evaluation and Mitigation Strategies (REMS).
  9. Safety Communication: Communicating safety information to healthcare professionals, patients, and regulatory agencies.
  10. Post-Marketing Surveillance: Continuously monitoring the safety of approved drugs in the market.
  11. Periodic Safety Reports: Preparing and submitting periodic safety reports, such as Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs).
  12. Quality Assurance: Ensuring compliance with standard operating procedures (SOPs) and quality control measures in pharmacovigilance activities.
  13. Pharmacovigilance Audits: Conducting internal audits or participating in external audits to assess compliance with regulatory standards.
  14. Pharmacovigilance Training: Providing training and guidance to staff on pharmacovigilance processes and regulations.
  15. Drug Safety Surveillance Systems: Implementing and managing systems for the continuous monitoring of drug safety.
  16. Advisory Role: Offering expert guidance and recommendations to product development teams, regulatory affairs, and other stakeholders.
  17. Collaboration: Collaborating with cross-functional teams, including regulatory affairs, medical affairs, and clinical research, to ensure a comprehensive approach to drug safety.

These duties are essential for ensuring the safety and effectiveness of pharmaceutical products throughout their lifecycle, from development and clinical trials to post-marketing surveillance. Pharmacovigilance and drug safety professionals play a critical role in protecting public health and regulatory compliance.

What are the average salaries for pharmacovigilance and drug safety professionals in US?

Average Base Salary

$128,700

Per Year

$99K$0k

The average salary for pharmacovigilance and drug safety professionals is $128,700 per year in the United States.

How much do similar professions get paid in the United States?

Profession

Job openings

Average $ per hour

Frequently Asked Questions about pharmacovigilance and drug safety

Pharmacovigilance and drug safety professionals typically work in pharmaceutical companies, biotech firms, regulatory agencies, or healthcare organizations. The work environment is office-based, collaborative, and detail-oriented. Remote work options are becoming more common, offering flexibility. The focus is on ensuring the safety and compliance of pharmaceutical products.

Pharmacovigilance and drug safety professionals can advance their careers by pursuing advanced degrees (e.g., Pharm.D., MPH), gaining diverse experience, pursuing certifications (e.g., RAPS, CCDS), and staying updated with regulatory changes. Networking, mentorship, and seeking leadership roles also enhance career growth in this critical field.

Skills essential for pharmacovigilance and drug safety experts include a strong understanding of pharmacology, knowledge of regulatory requirements, proficiency in safety database management, adverse event assessment, risk analysis, effective communication, attention to detail, regulatory reporting, and the ability to work in a collaborative, multidisciplinary environment. Additionally, a thorough understanding of medical terminology and the drug development process is crucial for success in this role.

Yes, there are certifications available for pharmacovigilance and drug safety professionals. Some notable certifications include the Regulatory Affairs Professional Society (RAPS) certifications and the Certified Clinical Drug Safety (CCDS) credential, which validate expertise in regulatory compliance and drug safety management. These certifications enhance career prospects and demonstrate proficiency in the field.

The career outlook for pharmacovigilance and drug safety professionals is promising. With increasing regulatory scrutiny and the importance of drug safety in healthcare, the demand for these experts remains high. Opportunities exist in pharmaceutical companies, regulatory agencies, contract research organizations (CROs), and healthcare institutions. Staying updated with evolving regulations and pharmacovigilance methodologies is essential for long-term success in this critical field.

Project Management and Support salary in the United States

Average Base Salary

$128,700

Per Year

$99k$0k

The average salary for project management and support is $128,700 per year in the United States.

0%

Salary satisfaction

Based on 4 ratings

50% of Pharmacovigilance Managers in the United States think their salaries are enough for the cost of living in their area.

How much do similar professions get paid in the United States?

Profession

Job openings

Average $ per hour

How to Become a Pharmacovigilance and Drug Safety Professional


To become a pharmacovigilance and drug safety professional, follow these steps:

  1. Educational Foundation:
    • Obtain a bachelor's degree in pharmacy, medicine, life sciences, nursing, or a related field.
    • Consider pursuing a master's degree (e.g., MPH) or postgraduate diploma in pharmacovigilance for specialized training.
  2. Pharmacovigilance Knowledge:
    • Gain a deep understanding of pharmacovigilance principles, regulations, and best practices.
  3. Regulatory Understanding:
    • Familiarize yourself with pharmaceutical regulations and guidelines, such as ICH, FDA, EMA, and local regulatory authorities.
  4. Drug Development Process:
    • Learn about the drug development lifecycle, including clinical trials, regulatory submissions, and post-marketing surveillance.
  5. Safety Database Management:
    • Acquire skills in using pharmacovigilance databases and tools for adverse event reporting and safety assessments.
  6. Adverse Event Assessment:
    • Develop expertise in evaluating and classifying adverse events and assessing causality.
  7. Reporting Requirements:
    • Understand the regulatory reporting requirements for adverse events and safety data.
  8. Risk Management:
    • Learn risk management strategies, including Risk Evaluation and Mitigation Strategies (REMS).
  9. Medical Terminology:
    • Familiarize yourself with medical terminology and clinical trial documentation.
  10. Soft Skills:
    • Enhance communication, attention to detail, and problem-solving skills, as these are essential in pharmacovigilance roles.
  11. Certifications:
    • Consider pursuing relevant certifications such as the Certified Pharmacovigilance Professional (CPP) or the RAPS Regulatory Affairs Certification (RAC).
  12. Internships and Experience:
    • Seek internships or entry-level positions in pharmacovigilance or related roles to gain practical experience.
  13. Networking:
    • Build a professional network by attending pharmacovigilance conferences, joining industry associations, and connecting with mentors.
  14. Continuous Learning:
    • Stay updated with evolving regulations, pharmacovigilance methodologies, and industry trends through ongoing education and professional development.
  15. Ethical Conduct:
    • Uphold ethical standards and confidentiality when handling sensitive pharmacovigilance data.

By following these steps and continually improving your knowledge and skills, you can embark on a rewarding career in pharmacovigilance and drug safety, contributing to public health and the safe use of pharmaceutical products.

What skills help pharmacovigilance and drug safety professionals find jobs?

Skills that can help pharmacovigilance and drug safety professionals find jobs include:

  1. Regulatory Knowledge: Understanding of pharmaceutical regulations and guidelines, such as ICH, FDA, and EMA.
  2. Pharmacovigilance Expertise: Proficiency in pharmacovigilance principles, adverse event reporting, and safety assessment.
  3. Database Management: Skills in using pharmacovigilance databases and software for data management and reporting.
  4. Risk Assessment: Ability to assess and manage risks associated with pharmaceutical products.
  5. Clinical Trial Understanding: Knowledge of the drug development process, clinical trial phases, and clinical documentation.
  6. Communication Skills: Effective written and verbal communication for regulatory reporting and collaboration with cross-functional teams.
  7. Attention to Detail: Precision in reviewing and classifying adverse events and safety data.
  8. Problem-Solving: Critical thinking to analyze complex safety issues and recommend solutions.
  9. Medical Terminology: Familiarity with medical terminology and clinical trial documentation.
  10. Soft Skills: Strong teamwork, adaptability, and the ability to work in a multidisciplinary environment.
  11. Certifications: Relevant certifications, such as Certified Pharmacovigilance Professional (CPP) or RAPS Regulatory Affairs Certification (RAC), can enhance job prospects.
  12. Ethical Conduct: Commitment to upholding ethical standards and maintaining confidentiality in pharmacovigilance activities.
  13. Continuous Learning: Staying updated with evolving regulations and pharmacovigilance methodologies through professional development and education.
  14. Networking: Building a professional network within the pharmaceutical industry to access job opportunities and career growth.

Demonstrating these skills, whether through education, certifications, or practical experience, can make pharmacovigilance and drug safety professionals highly sought-after in the industry.


All Jobs: 23

Found Jobs: 23

Showing 1 - 23 | Page 1 of 1
 

Network Engineer

Job ID: 7945
Location: Media, PA  [Hybrid]
Employment Type: Contract To Hire
Consultant for Hybrid role in Media PA will design and build a resilient cutting-edge secure network infrastructure. Consultant will be responsible for the design, engineering, deployment, documentation, optimization, and problem management of all enterprise network infrastructure. Duties will include (but are not limited too): Configuration of firewalls and firewall rule sets Work with proxy services,…

Senior (Voice/Data) Project Management Specialist

Job ID: 7944
Location: Dover, DE  [Hybrid]
Employment Type: Contract
We are seeking an experienced Senior Project Management Specialist 2 to lead the migration of our client’s enterprise voice system from an on-premise Cisco Unified Communications Manager platform to a Cisco WebEx Cloud calling platform. Contact us for more details. …

Business Analyst

Job ID: 7943
Location: Dover, DE  [On-Site]
Employment Type: Contract
The BA in this role will serve as the eCR (Electronic Case Reporting) Lead and a dedicated resource to advance the implementation of eCR for all reportable conditions and to accelerate the use of this data to support our client's programs. Contact us for more details. …

Senior Project Manager

Job ID: 7942
Location: Dover, DE  [On-Site]
Employment Type: Contract
The Senior Project Manager (SPM) is responsible for managing, coordinating, and establishing priorities for the complete life-cycle of projects including the planning, design, programming, testing, and implementation of business solutions designed to meet requirements of various departments in the company, such as distribution, finance, and manufacturing. Senior Project Managers are…

C# Software Engineer

Job ID: 7940
Location: Dover, DE  [On-Site]
Employment Type: Contract
We are looking for a strong C# Software Engineer to join our Delaware based client's Platform Engineering team. You will assist with the support, design, implementation, and testing of products by for client.…

Senior Full Stack Java Software Engineer

Job ID: 7939
Location: Wilmington, DE  [Hybrid]
Employment Type: Direct Hire
We are looking for a Senior Full Stack Java Software Engineer for one of our Wilmington based financial services clients. On the Enterprise Application Engineering team, you serve as a member to design and deliver trusted market-leading technology products in a secure, stable, and scalable way. Your extensive technical…

ServiceNow Solutions Engineer

Job ID: 7938
Location: Dover, DE  [Remote]
Employment Type: Contract
We are looking for a ServiceNow Solutions Engineer for a 20-month Remote contract engagement. Candidates should have... • Strong Functional and Technical knowledge of the Platform providing guidance and support to deliver solutions. • Experience in maintaining CMDBs, Asset Management and other Asset/Configuration Management repositories. Excellent understanding of Infrastructure configurations, CI classes and their…

Sr Data Engineer

Job ID: 7936
Location: Titusville, NJ  [Remote]
Employment Type: Contract
Sr. Data Engineer Requirements: - Should have 5-8+ Years of IT Experience with Data Engineering and DWH, ETL Data Bases, ETL Pipelines, data migration. - 5-8+ years' experience working with data bases like - Oracle/ SQL, and very strong with SQL Queries. - Should have experience with Python. - Should know some Data…

UI/UX Designer

Job ID: 7935
Location: Dover, DE  [Remote]
Employment Type: Contract
The UI designer will work within the Creative Team and will have a strong collaboration with the Web Team. …

Residential Electrical Designer

Job ID: 7934
Location: Fairfax, VA  [Hybrid]
Employment Type: Direct Hire
Residential Electrical Designer role involves designing electrical systems for residential, multifamily residential, and light commercial projects using industry-leading modeling software. The position requires strong knowledge of electrical engineering fundamentals and experience in the construction industry.…

IT Project Manager

Job ID: 7933
Location: Beverly Hills, CA  [On-Site]
Employment Type: Contract
• Define project scope, goals, and deliverables in collaboration with senior management and stakeholders. • Develop full-scale project plans and associated communications documents. …

IT Project Specialist

Job ID: 7932
Location: Beverly Hills, CA  [On-Site]
Employment Type: Contract
• User Support and Training: Provide support to users on IT-related issues, train staff on new technologies, and assist with troubleshooting hardware or software problems.…

Sr. Project Management Specialist

Job ID: 7931
Location: Dover, DE  [Hybrid]
Employment Type: Contract
We are looking for a Project Management Professional for a 12-month contract engagement with one of our New Castle, Delaware based clients. A successful candidate providing project management expertise will have the following: Fiscal process background, project management certifications, Health Information Technology (HIT) knowledge, and experience with implementation of…

BA

Job ID: 7930
Location: Berwyn, PA  [Hybrid]
Employment Type: Direct Hire
Confidential posting. Please contact PSCI for more details.…

Project Manager

Job ID: 7929
Location: Washington, DC  [Remote]
Employment Type: Contract
The project manager will work with the project team to create project plans for each project, including timelines, resources, dependencies and critical path in Monday.com. They will ensure that tasks are identified, risks are identified and tracked, and that each element of the project plan is on schedule. The…

Content Writer / Researcher

Job ID: 7916
Location: Wilmington, DE  [Hybrid]
Employment Type: Contract
Web Content Researcher - Hybrid (mostly remote) role in Wilmington, Delaware. Contact us for more details.…

Data Engineer

Job ID: 7912
Location: Camden, NJ  [Hybrid]
Employment Type: Contract
Overview  PSCI is  seeking a Data Engineer for hybrid work at our client in Camden NJ. This is a 3-6 month contract Bachelor's degree in computer science, information technology, or related field 3+ years of experience in data analytics or business intelligence-related role Experience in analytical or data visualization tools Conceptual knowledge of data and…

Workday Reports Developer

Job ID: 7906
Location: Media, PA  [On-Site]
Employment Type: Direct Hire
Our client is looking for a permanent employee to join their Workday team. The Senior Data Analyst and Report Developer is responsible for partnering with each corporate function and business unit along with our client's HR Systems team to optimize the use of Workday data and applications, specifically through the analytics,…

ENGINEER QA – MP&A

Job ID: 7631
Location: Philadelphia, PA  [Remote]
Employment Type: Direct Hire
Collaborate with business stake holders & product owners to identify, analyze and come up with technical orchestration of business process with the latest tools available.…

Sr Principal Biostatistical Programmer

Job ID: 7249
Location: Wilmington, DE  [On-Site]
Employment Type: Direct Hire
The Sr Principal, Biostatistical Programmer is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials and leading project teams. Qualifications • BA/BS degree (MS degree in statistics or computer sciences is desired). • Minimum 8 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO…

Senior Biostatistician to Director, Biostatistics

Job ID: 7248
Location: Wilmington, DE  [On-Site]
Employment Type: Direct Hire
The Senior Biostatistician to Director, Biostatistics is responsible for providing statistical support for drug development programs in all phases of development. Essential Functions of the Job (Key responsibilities) Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and…

Lead SAS Programmer

Job ID: 7247
Location: Wilmington, DE  [On-Site]
Employment Type: Direct Hire
The Lead Biostatistical Programmer I is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, and leading project teams. Qualifications • Bachelor’s degree in Statistics, Mathematics, Computer Science or health related field. Masters is preferred. • Minimum 5 years of programming experience using SAS Base/Stat/Macro/GRAPH in…

Senior Biostatistician

Job ID: 7246
Location: Wilmington, DE  [On-Site]
Employment Type: Direct Hire
The Senior Manager, Biostatistics to Director, Biostatistics is responsible for providing statistical support to drug development programs. Essential Functions of the Job (Key responsibilities) • Interact with members of the multidisciplinary project teams to establish project timelines. • Provide statistical input to…