Senior Associate, Pharmacovigilance Coordinator

The role

The Pharmacovigilance Coordinator manages the day-to-day operations of Pharmacovigilance. This includes managing the PV inbox, tracking vendor safety deliverables, and supporting commercial safety data reconciliations.

What you will do

• Monitor and triage the shared PV mailbox daily.
• Log incoming items and escalate time-sensitive safety information.
• File correspondence and supporting documentation in the PV repository.
• Track individual case safety reports through the vendor's case processing workflow.
• Escalate cases at risk of missing regulatory or internal timelines.
• Assist in safety vendor oversight activities including tracking KPIs and compliance metrics.
• Maintain case tracking logs and support periodic reporting.
• Support periodic reconciliations of adverse events across commercial sources.
• Oversee receipt of scheduled line listings and other safety outputs from the PV vendor.
• Own the PV deliverable calendar and schedule PV meetings.

Required qualifications

• 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.
• High attention to detail.
• Clear written and verbal communication with internal teams and external vendors.
• 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.

Nice to have

• Bachelor's degree in life sciences, pharmacy, nursing, health sciences, or a related field
• Proficiency with Microsoft Outlook, Excel, Teams, and SharePoint

Benefits

• Competitive salary, bonus, and ongoing stock awards
• 100% medical, dental, and vision premiums for employee and family
• Funding up to 75% of in-network deductibles
• 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
• Company-paid short-term disability coverage for up to 20 weeks
• Wellness programs
• Tuition reimbursement
• Inclusive family-forming support
• Free on-site parking and gym facilities in the building

About the company

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs.