Senior Pharmacovigilance Operations Lead

Cogent Biosciences, Inc.; Waltham, Northern (MA, KY); Hybrid; USD 100,000 - 115,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Stock awards

Medical, dental, and vision premiums I

Job summary

Cogent Biosciences, Inc. in Waltham, MA is seeking a Senior Associate, Pharmacovigilance Coordinator to keep PV operations running, manage the PV inbox, and support regulatory-ready records. You will monitor vendor safety deliverables, reconcile data, and maintain the PV calendar.

The role focuses on organized, detail-oriented work with collaboration across vendors and internal teams to ensure timely safety reporting and audit readiness. This is a hands-on position with growth in PV operations.

Qualifications

• Bachelor's degree in life sciences or related field preferred.
• At least 1 year in pharmacovigilance or drug safety.
• Working knowledge of US FDA safety regulations; familiarity with ICH and GVP guidelines.
• Strong organization and follow-through; able to manage many recurring deadlines at once.
• Clear written and verbal communication with internal teams and external vendors.

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 and follow up with the vendor on gaps or delays.
• Distribute line listings to internal and external recipients defined in the distribution matrix; 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 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.

Skills

Pharmacovigilance

Regulatory knowledge

Organization & multitasking

Communication skills

MS Office/SharePoint

Education

Bachelor's degree in life sciences

Tools

Argus Safety

Job description

Cogent Biosciences, Inc. in Waltham, MA is seeking a Senior Associate, Pharmacovigilance Coordinator to keep PV operations running, manage the PV inbox, and support regulatory-ready records. You will monitor vendor safety deliverables, reconcile data, and maintain the PV calendar.

The role focuses on organized, detail-oriented work with collaboration across vendors and internal teams to ensure timely safety reporting and audit readiness. This is a hands-on position with growth in PV operations.