Associate Director, Pharmacovigilance Operations

The Opportunity 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. Your Role:

• 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.

Your Background:

• 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

Estimated Salary Range: [$145,000 - $207,000]. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location. #BP1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! Apply tot his job Apply To this Job