--- title: 'Senior Associate, Pharmacovigilance Coordinator at Cogent Biosciences' canonical: 'https://feeny.ai/job/senior-associate-pharmacovigilance-coordinator-cogent-biosciences-waltham-605v8frhmdj6' type: 'job' last_seen: '2026-10-14' --- # Senior Associate, Pharmacovigilance Coordinator at Cogent Biosciences - **Company:** Cogent Biosciences - **Location:** Waltham, MA - **Posted:** 2026-10-05 - **Last confirmed live:** 2026-10-14 - **Apply:** https://job-boards.greenhouse.io/cogentbiosciences/jobs/4425822009 ## Job description Who We Are: 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. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 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 Locations Waltham, 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 You At 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. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need. ## About Cogent Biosciences ## Company Overview - **One-liner**: Cogent Biosciences is a publicly traded biotechnology company developing precision therapies for genetically defined diseases, with its lead program bezuclastinib targeting KIT D816V mutations in systemic mastocytosis and gastrointestinal stromal tumors. - **Entity Type**: Public (NASDAQ: COGT) - **Headquarters**: Waltham, Massachusetts, United States (with additional office in Boulder, Colorado) - **Founded**: 2014 - **Founders**: Not publicly available ## Core Business - **Primary industry**: Biotechnology research and therapeutics development - **Target customers**: Patients with genetically defined diseases, healthcare providers, and pharmaceutical partners (B2B/B2C hybrid) - **Mission**: “To discover, develop, and commercialize best-in-class therapies that have a dramatic impact for patients with genetically defined diseases” [cogentbio.com](https://www.cogentbio.com/) ## Products & Services - **Bezuclastinib**: A selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other KIT exon 17 mutations. In late-stage clinical development for advanced systemic mastocytosis (AdvSM), non‑advanced SM, and advanced gastrointestinal stromal tumors (GIST). Positive registration‑directed trial results reported in 2025. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences) - **Novel JAK2 V617F inhibitor**: A potential best‑in‑class mutant‑selective JAK2 inhibitor currently in preclinical development, with data presented at the 2026 EHA Congress. [cogentbio.com](https://www.cogentbio.com/) - **Additional pipeline programs**: Research‑stage targeted therapies addressing mutations in ErbB2, PI3Kα, KRAS, and JAK2. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences) ## Market Standing - **Valuation/Market Cap**: USD $762.7 million (as of mid‑2026, based on LinkedIn data) [linkedin.com](https://www.linkedin.com/company/cogentbiosciences) - **Key Metric**: Annual revenue of USD $7.9 million (likely from partnerships or grants); total funding to date ~USD $1.82 billion (including post‑IPO equity, debt, and Series A). [linkedin.com](https://www.linkedin.com/company/cogentbiosciences) - **Notable Investors/Partners**: Series A led by Atlas Venture and F‑Prime; post‑IPO equity rounds led by Commodore Capital (2024, $225M), Fairmount Funds Management (2020, $104.4M) [linkedin.com](https://www.linkedin.com/company/cogentbiosciences) - **Growth Signals**: Headcount grew 27.6% year‑over‑year to 223 employees; monthly LinkedIn follower growth of 3.0% (+61.7% annually); positive late‑stage trial results in 2025; expanded pipeline with new preclinical assets. [linkedin.com](https://www.linkedin.com/company/cogentbiosciences) ## Competitive Advantages - **Selective targeting of KIT D816V**: Bezuclastinib is designed to selectively and potently inhibit the key driver mutation in systemic mastocytosis, potentially offering a better safety/tolerability profile than earlier multi‑kinase inhibitors. - **Late‑stage momentum**: Registration‑directed trials (APEX pivotal trial) have reported clinically meaningful results, positioning the company for potential regulatory submissions and commercialization. - **Broad pipeline beyond KIT**: Research into JAK2, KRAS, PI3Kα, and ErbB2 mutations diversifies the platform and reduces single‑asset risk. - **Strong capital position**: Over $760M market cap and access to public equity markets provide financial runway for multiple programs. ## Strategic Focus - **Advance bezuclastinib to market**: Continue regulatory interactions and preparation for potential FDA approval in AdvSM and GIST, while expanding into non‑advanced SM. - **Build a portfolio of precision therapies**: Invest in early‑stage discovery (Boulder, CO) to generate novel molecules targeting validated oncogenic drivers. - **Commercial readiness**: Hiring commercial leadership (Chief Commercial Officer, Market Access, Field Medical Affairs) indicates preparation for a future product launch. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences) ## Why Work Here - **Culture**: Emphasizes collaboration, urgency, inquisitiveness, and ingenuity. Corporate values include “Patients are waiting” (urgency), “Learning excites us” (inquisitiveness), “Succeed Together” (trust), and “Navigate uncertainty” (ingenuity). [cogentbio.com](https://www.cogentbio.com/careers/) - **Work model**: Hybrid/remote flexibility – many roles are listed as remote (e.g., Area Directors for Field Medical Affairs, Patient Educators), while research roles are onsite in Boulder, CO. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences) - **Growth and impact**: As a late‑stage clinical company with an expanding pipeline, employees have direct influence on programs that could change patient lives. Fast‑paced environment with high autonomy. ## Sources 1. [Cogent Biosciences Corporate Website](https://www.cogentbio.com/) 2. [Cogent Biosciences About Page](https://www.cogentbio.com/about/) 3. [Cogent Biosciences Careers Page](https://www.cogentbio.com/careers/) 4. [Cogent Biosciences Job Board (Greenhouse)](https://job-boards.greenhouse.io/cogentbiosciences) 5. [Cogent Biosciences LinkedIn Profile](https://www.linkedin.com/company/cogentbiosciences) ## Other roles at Cogent Biosciences - [Associate Director, Accounting Operations](https://feeny.ai/job/associate-director-accounting-operations-cogent-biosciences-waltham-mnsd4hanythw) — Waltham, MA - [Associate Director, Training and Contract Operations](https://feeny.ai/job/associate-director-training-and-contract-operations-cogent-biosciences-waltham-0batp7n1zpdd) — Waltham, MA - [Manager, Cost Accounting](https://feeny.ai/job/manager-cost-accounting-cogent-biosciences-waltham-r0e52v91m7rb) — Waltham, MA - [Senior Director, Global Market Access](https://feeny.ai/job/senior-director-global-market-access-cogent-biosciences-waltham-ryr14ebyxz55) — Waltham, MA - [Scientist, DMPK (BioAnalytical and Medical Writing)](https://feeny.ai/job/scientist-dmpk-bioanalytical-and-medical-writing-cogent-biosciences-boulder-r2b31gdpf60e) — Boulder, CO - [Director, National Payer Accounts](https://feeny.ai/job/director-national-payer-accounts-cogent-biosciences-waltham-5jkvd1gj4bg7) — Waltham, MA - [Director, Patient Advocacy & Engagement](https://feeny.ai/job/director-patient-advocacy-engagement-cogent-biosciences-waltham-mdfqz22t61ny) — Waltham, MA - [Manager, Communications and Investor Relations](https://feeny.ai/job/manager-communications-and-investor-relations-cogent-biosciences-waltham-am68edvhn0v0) — Waltham, MA - [Associate Director, Translational Medicine](https://feeny.ai/job/associate-director-translational-medicine-cogent-biosciences-waltham-rj8yex8parvp) — Waltham, MA - [Director, Corporate Counsel](https://feeny.ai/job/director-corporate-counsel-cogent-biosciences-waltham-re6398tj5cwt) — Waltham, MA