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.