Associate Director, Pharmacovigilance Operations

Relay Therapeutics•Cambridge, MA

About The Position

The Associate Director, PV Operations is responsible for developing and leading key PSRM operational functions, including case management oversight and compliant global ICSR and aggregate safety reporting. This role is responsible for oversight of safety operations activities including but not limited to collection, management and reporting of SAE and other safety information from clinical programs, maintenance and updates to safety database and ensuring compliance to Safety Data Agreements and global regulatory requirements. The position partners closely with clinical development and program teams to guide safety management throughout Relay’s portfolio.

Requirements

Experience in global program support required; experience in oncology programs, is preferred.
Expertise in case management oversight and global safety reporting compliance.
Significant experience with Safety Data Exchange Agreements/Pharmacovigilance Agreements and partner management.
Demonstrated competency in safety vendor oversight and inspection readiness.
Proven ability to manage complex safety data flows and ensure reporting compliance.
Advanced knowledge of global PV regulations, including US CFR, EU GVP, and ICH guidelines.
Proficiency with drug safety databases, preferably Argus.
Excellent communication skills.
Minimum of 6 years of relevant industry experience, including 4 years in drug safety.
Healthcare degree: RN or PharmD preferred

Responsibilities

Develop and maintain departmental SOPs, work instructions, and guidelines related to SAE processing and reporting.
Maintain regulatory reporting calendars and global reporting requirement matrices.
Create and update study-specific safety management plans in collaboration with study teams.
Lead SAE-related study start-up activities and oversee CRO case management operations, including database maintenance.
Oversee timely submission and distribution of expedited safety reports to regulatory authorities, investigators, CROs, and partners.
Collaborate with data management to develop SAE eCRFs for Relay-sponsored studies.
Oversee Safety Service Provider-executed safety operations activities related to SAE management, ICSR reporting, and aggregate reporting.
Develop and maintain safety templates and forms with cross-functional stakeholders and CROs.
Contribute to safety content in, protocols, CRFs, CSRs and regulatory submissions.
Ensure internal personnel are trained in pharmacovigilance principles, policies/procedures and external personnel are trained in safety reporting requirements & procedures.
Manage the Relay safety mailbox.