Advantage Technical
Drug Safety Scientist (Waltham)
Advantage Technical, Waltham, Massachusetts, United States, 02254
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
$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