Pharmacovigilance and Risk Management (PVRM) Lead will serve as point of contact for cross functional development teams and is involved in all safety surveillance activities, including review of individual safety cases, signal detection/evaluation and risk management activities.
Serve as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments Performs Review of adverse event reports including but not limited to all serious, events of interest, and expedited individual case safety reports ensuring that appropriate interpretation, consistency and quality are applied to adverse event case assessment.
Generates or assists with input to Analysis of Similar Events Participates in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development Performs review of coding (eg.
reaction, suspect/concomitant product, indication, laboratory data, medical history) Provides support for investigator brochures, protocols, informed consents, final study reports, as appropriate.
Provides safety guidance for aggregate reports, DCSI, CDS, IB and ad hoc regulatory responses.
Lead the strategy for safety issue evaluation and management for the life cycle of product.
Contributes to signal detection, monitoring, evaluation, interpretation and appropriate management of safety information Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development and updates/maintenance of expectedness guides.
Prepares and may present individual case safety report issues, aggregate data analyses, interpretation and strategies for submission documents such as the ISS, SCS and proposed risk mitigation strategies for discussion at internal meetings.
Participate in ad-hoc projects or assignments that require medical input.
Location/Region: Marlborough, MA (US)