Job Description
Job Title: Pharmacovigilance Scientist (Contract)
Position Summary The Pharmacovigilance Scientist contractor supports safety data analysis for investigational and marketed products in collaboration with the PV Sciences Team and Safety Physician. The role involves signal management, aggregate safety reporting, RMP/REMS support, literature surveillance, and safety analyses for regulatory submissions and clinical trial documents. The position also contributes to process improvements and ensures compliance with global PV regulations. Reports to the Associate Director, PV Scientist.
Key Responsibilities
- Conduct signal management and safety data analyses.
- Prepare and review aggregate safety reports (DSURs, PADERs, PBRERs).
- Support RMP updates, REMS reports, and ad hoc safety queries.
- Perform literature surveillance for marketed and investigational products.
- Ensure compliance with global PV guidelines (CIOMS, EMA, FDA, ICH).
- Contribute to SOP/WI updates and process improvement initiatives.
- Maintain inspection readiness.
Qualifications
- 2-3 years of relevant medical, scientific, or pharmaceutical experience in drug safety/PV.
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS).
- Strong skills in data analysis, interpretation, and clinical judgment.
- Excellent communication and ability to work independently and cross-functionally.
- Knowledge of PV regulations, case processing, expedited reporting, and safety databases.
- Proficiency in Microsoft Office and Argus Safety systems.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Job Tags
Full time, Contract work, For contractors, Work at office,