Senior Director, Pharmacovigilance Quality and Compliance

Cogent Biosciences•Waltham, MA

11d

About The Position

The Pharmacovigilance (PV) Quality and Compliance Senior Director is responsible for leading assigned PV quality and compliance activities based on relevant regulations, procedures, and contractual requirements. Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will implement processes for the management of all PV controlled procedures, PV training, PV files, CAPAs and inspection related activities, as well as leading a QC system for all relevant PV documents. The Senior Director, PV Quality and Compliance will design a global PV training program, including the implementation, tracking, and maintenance of all PV training activities, and will foster a culture of Inspection Readiness and continuous process improvement. The incumbent will support the organization and maintenance of a PV compliance system with appropriate metrics. This role will provide global leadership for PV compliance in the PV department and in other Cogent functions / departments who perform PV-related activities. Proactive and insightful analytical and management skills are required, including an understanding of how to interpret business requirements, make strategy adjustments when necessary and translate them into efficient processes. Effective communication, project management, and compliance management tracking, reporting, and problem solving will be core skillsets for this role.

Requirements

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

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