Associate Director, Drug Safety and Pharmacovigilance Operations
Listed on 2026-01-12
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Healthcare
Healthcare Administration, Healthcare Management
Associate Director, Drug Safety and Pharmacovigilance Operations
Join to apply for the Associate Director, Drug Safety and Pharmacovigilance Operations role at Rapport Therapeutics
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When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).
Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.
High visibility role as DSPV Operations Lead, will play a critical, strategic and hands‑on operational role in supporting PV across all clinical development programs.
Your Day‑to‑Day Clinical Trial Support- Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuring compliance with regulatory timelines and global regulations and guidelines.
- Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange.
- Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans.
- Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
- Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables.
- Collaborate cross‑functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to.
- Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
- Lead DSPV Trial Master File document review, QC and provision to study specific TMFs.
- Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick‑Off Meeting activities, requests for and attainment of information from cross‑functional teams.
- Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.
- Lead day‑to‑day operational oversight of pharmacovigilance service provider.
- Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals.
- Obtain close oversight of ICSR quality including performance of QC as needed.
- Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back‑up testing, and other activities as required.
- Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance.
- Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
- Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities.
- Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices,…
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