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

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