Advantage Technical
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
Benefits
Medical insurance
Vision insurance
401(k)
Seniority level Mid‑Senior level
Employment type Contract
Job function Science
Industries Pharmaceutical Manufacturing
Location Get notified about new Scientist jobs in Waltham, MA.
#J-18808-Ljbffr
$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
Benefits
Medical insurance
Vision insurance
401(k)
Seniority level Mid‑Senior level
Employment type Contract
Job function Science
Industries Pharmaceutical Manufacturing
Location Get notified about new Scientist jobs in Waltham, MA.
#J-18808-Ljbffr