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.

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