Associate Director, Safety Ops

Darum lohnt es sich

Contributes to the enhancement of pharmacovigilance processes and systems to support program advancement and global expansion. /ph3Key Accountabilities / Core Job Responsibilities /h3ulliOversee global pharmacovigilance operations for assigned clinical programs /liliEnsure compliant safety case intake, processing, reporting, and reconciliation across all sources (including clinical studies and post-marketing sources) /liliOversee safety case management activities to ensure adherence to global regulatory requirements, company procedures, and reporting timelines /liliManage pharmacovigilance vendors and external partners, ensuring performance, compliance, and alignment with contractual and operational expectations /liliLead the development and oversight of safety data exchange agreements (SDEA) / PV Agreements (PVA) with license partners and/or other parties /liliDrive continuous improvement of pharmacovigilance processes, systems, and workflows to enhance efficiency and quality /liliLead the planning and operational delivery of aggregate safety reports (e.g., DSUR, PBRER, PADER) /liliPartner cross-functionally with Clinical, Regulatory, Safety Science, and other stakeholders to ensure effective adverse event handling and communication /liliMonitor pharmacovigilance compliance metrics (KPIs/KQIs), identify trends, and implement corrective and preventive actions as needed /liliSupport regulatory inspections, audits, and inspection readiness activities, including documentation and response preparation /liliContribute to the development and maintenance of pharmacovigilance procedures and training to ensure organizational awareness and compliance /liliSupport safety-related inputs into clinical and regulatory documents (e.g., protocols, Safety Management Plans, MA submissions) /liliSupport the implementation of safety procedures related to the company international market expansion efforts /li /ulh3Qualifications / Skills /h3ulliTypically requires a Bachelor’s degree and 12+ years of relevant experience, or an equivalent combination of education and experience, with strong focus on pharmacovigilance safety operations in a global environment /liliDemonstrated expertise in global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH) /liliExperience managing vendors and external partners supporting pharmacovigilance activities /liliProven ability to independently lead complex, cross-functional initiatives and manage multiple priorities /liliExperience supporting regulatory inspections and audits within a pharmacovigilance system /liliStrong communication, organizational, and problem-solving skills with ability to operate effectively in a fast-paced, matrixed environment /liliExperience in both pre-approval and post-marketing pharmacovigilance activities /li /ulpCompensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. /ppDenali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits. /ppWe are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class. /p /p ppLeads the execution and continuous improvement of global pharmacovigilance operations to ensure compliant, efficient, and high-quality safety data management across clinical and post-marketing programs.

Drives cross-functional coordination and vendor oversight to support timely adverse event reporting, inspection readiness, and regulatory compliance.