The Role:- 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.
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.
Qualifications:- 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.
Salary Range:$100,00 - $115,000 USD
Target Bonus: 15%
Exact compensation will vary based on skills, experience, and location.
Our LocationsWaltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent's discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To YouAt Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
