Cogent Biosciences · 1 month ago
Senior Director, Pharmacovigilance Quality and Compliance
Waltham, MA
Full-time
Onsite
Director/Executive
$260K/yr - $300K/yr
8+ years expCogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. The Pharmacovigilance Quality and Compliance Senior Director will lead PV quality and compliance activities, implement tracking tools, and design global training programs while fostering a culture of continuous improvement.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead Cogent PV process improvements including authoring and updating controlled procedures; maintaining the PV procedures Index
Represent PV on cross-functional learning initiatives within Cogent and externally with business partners, as applicable. Where there is cross-reference and/or cross functionality with other Cogent controlled procedures, ensure PV SOP alignment and compliance
Serve as the primary point of contact for PV controlled documents (i.e. SOPs, WIs, etc.) and PV training and as the subject matter expert for these topics during audits and inspections
Develop, provide and track training based on regulatory requirements, applicable internal and external procedures, contractual requirements, scientific best practices to internal and external stakeholders
Manage all PV controlled procedures, training, CAPAs, and a QC system for applicable PV documents
Monitor PV non-conformance trends and communicate this information to PV management with proposed remediation actions
Support GCP Quality Assurance (QA) by engaging and providing support of the R&D QA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functionality
Assist in PV activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
Track PV commitments from internal audits, regulatory inspection findings, and CAPAs
Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
Support PV compliance and alliance activities with vendors and business partners and participate in Pharmacovigilance Agreement (i.e., SDEA) creation and revision
Responsible for the preparation of Key Quality Indicators (KQIs) and Compliance Metrics for PV
Responsible for the preparation of monthly PV compliance reports, including relevant metrics, to key stakeholders and management
Alerts PV management of significant deficiencies in quality and compliance standards
Oversees the development of corrective and preventative actions related to non-compliance with PV, and external vendor(s)
Responsible to review, monitor and trend in root cause analyses from non-compliance metrics
Monitor global pharmacovigilance regulatory intelligence to determine impact on Cogent PV’s pharmacovigilance quality system and develop strategies to support PV at the local level
Responsible and accountable for the management of the Pharmacovigilance System Master File (PSMF) and similar documents as required globally
Collaborates, liaises and supports all Cogent functional groups responsible for contributing to the PSMF, ensuring they provide the required information on time for the PSMF
Responsible to update, maintain, and support the PV Business Continuity Plan (BCP)
Accountable and responsible to ensure the BCP is updated as necessary and tested annually and documented/archived
Qualification
Required
BS/MS degree in a scientific or technical discipline
Must have a minimum of 8-10 years of experience in the areas of GXP regulations with a minimum of 5 years of experience in a quality and compliance role within pharmacovigilance
Experience leading and managing pharmacovigilance regulatory inspections and interfacing with Regulatory
Benefits
Competitive pay
Performance-based bonus
Stock options
Insurance coverage (health, dental, life, and disability)
Competitive time-off
A 401(k) plan
Commuter/parking benefits
Company
Cogent Biosciences
Cogent Biosciences is a biotechnology company that develops therapies for solid cancer tumors.
51-200 employees
H1B Sponsorship
Cogent Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.6BKey Investors
Commodore CapitalFairmount Funds ManagementSquare 1 Bank
2025-11-10Post Ipo Equity· $200M
2025-11-10Post Ipo Debt· $200M
2025-07-08Post Ipo Equity· $230M
Leadership Team
Andrew Robbins
President and Chief Executive Officer
A
Abb Hayden
Senior Vice President of Sales
Recent News
2025-12-31
Company data provided by crunchbase