Senior Associate, Pharmacovigilance Coordinator

Cogent Biosciences•Waltham, MA

3d•Hybrid

About The Position

The Pharmacovigilance Coordinator keeps the day-to-day engine of Pharmacovigilance (PV) Operations running. You will manage the PV inbox, track and distribute vendor safety deliverables, support commercial safety data reconciliations, and keep the PV deliverable calendar current. This is a hands-on role for an organized, detail-driven person who wants to build a career in PV within a growing team.

Requirements

Bachelor's degree in life sciences, pharmacy, nursing, health sciences, or a related field preferred.
At least 1 year in pharmacovigilance, drug safety, or a closely related function (medical information, clinical operations, quality).
Working knowledge of adverse event reporting concepts and US FDA safety regulations; familiarity with ICH and GVP guidelines.
Strong organization and follow-through; able to manage many recurring deadlines at once.
High attention to detail, especially when comparing data sets and documenting discrepancies.
Clear written and verbal communication with internal teams and external vendors.
Proficiency with Microsoft Outlook, Excel, Teams, and SharePoint preferred.
Experience with safety data reconciliation or safety data exchange with vendors or partners.
Exposure to a safety database such as Argus Safety.
Experience coordinating meetings, trackers, or calendars for a regulated function.

Responsibilities

Monitor and triage the shared PV mailbox daily; route safety information, vendor correspondence, and partner requests to the correct owner within defined timelines.
Log incoming items, track them to closure, and escalate time-sensitive safety information.
File correspondence and supporting documentation in the PV repository to keep records inspection-ready.
Track individual case safety reports through the vendor's case processing workflow, from receipt to submission.
Escalate cases at risk of missing regulatory or internal timelines to the Senior Director, PVRM Operations.
Assist in safety vendor oversight activities including tracking of KPIs, compliance metrics, and open query metrics.
Maintain case tracking logs and support periodic case volume and timeliness reporting.
Support periodic reconciliations of adverse events across commercial sources, such as patient support programs, medical information, specialty pharmacy, and hub.
Maintain reconciliation logs, sign-offs, and evidence for audits and inspections.
Oversee receipt of scheduled line listings and other safety outputs from the PV vendor; confirm they arrive on time and are complete.
Perform a first-pass quality check (correct period, format, and product) and follow up with the vendor on gaps or delays.
Distribute line listings to the internal and external recipients defined in the distribution matrix and safety data exchange agreements, if relevant; keep a record of each transmission.
Maintain the distribution list and recipient matrix as stakeholders change.
Own the PV deliverable calendar, including aggregate reports, line listings, reconciliations, and vendor deliverables; send reminders ahead of due dates and flag risks to on-time delivery.
Schedule and coordinate PV meetings, including vendor governance meetings, internal team meetings, and cross-functional safety meetings; prepare agendas, take minutes, and track action items.
Support audit and inspection readiness by maintaining organized, complete PV records and trackers.
Perform routine quality control of the PV CRO/Cogent SharePoint site to ensure documents, meeting minutes, and related records are properly maintained.
Help with SOP and work instruction updates, training records, and process improvement.
Take on other PV Operations tasks as assigned.