Job Description
Senior Pharmacovigilance (PV) Scientist
Pay Rate: $73/hour
Reports to: Senior Director of Drug Safety and Pharmacovigilance (DSPV)
Position Summary
The Senior PV Scientist plays a pivotal role in medical analytics and safety coordination for both marketed and investigational products. This position partners closely with the Safety MD/Medical Monitor and cross-functional teams to ensure high-quality safety data analysis, signal detection, and regulatory reporting. The role demands strong leadership, independent initiative, and a deep understanding of regulatory compliance and clinical safety processes.
Key Responsibilities
For Marketed Products:
- Coordinate and document safety surveillance activities with the safety physician
- Lead aggregate safety report development (PSUR, PADER, DSUR), including vendor oversight, data analysis, and quality control
- Manage literature review plans and provide feedback to vendors
- Prepare materials for routine and ad hoc Safety Governance meetings
- Respond to ad hoc safety queries (e.g., health authority requests, NISS, health hazard evaluations)
- Represent safety in cross-functional product meetings
For Investigational Products:
- Support updates to safety sections of Investigator Brochures, protocols, CRFs, and ICFs
- Contribute to DSMB presentations and ongoing safety data reviews (labs, AEs)
- Participate in protocol design and safety monitoring planning
- Conduct SAE reconciliation and coding reviews
General Duties:
- Maintain knowledge of evolving safety regulations and ensure SOP/work instruction compliance
- Drive process improvements and promote consistency across products
- Mentor junior PV Scientists and contribute to team development
- Perform other duties as assigned
Qualifications
- Minimum 5 years of relevant experience in medical, scientific, clinical, or pharmaceutical settings
- At least 3 years in a PV Scientist role within drug safety
- Strong analytical and communication skills (written and verbal)
- Proven ability to work independently and collaboratively across departments
- Effective project management and leadership capabilities
- Clinical judgment and experience interpreting case data
- Familiarity with pharmacovigilance regulations, case processing, and safety databases
- Proficiency in EXCEL, PowerPoint, Word, Business Objects, MedDRA, and Argus Safety System
Education
- Advanced degree required: PharmD, RN, MD, PhD, MPH, or NP
Job Tags