Senior PV Scientist Job at Advantage Technical, Waltham, MA

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  • Advantage Technical
  • Waltham, MA

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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