Associate Director, Drug Safety and Pharmacovigilance Operations

Rapport Therapeutics•Boston, MA

7h•Hybrid

About The Position

At Rapport, we are dedicated to developing precision neuromedicines, focusing on Receptor Associate Proteins (RAPs) to create therapies with fewer side effects. Our innovative scientific platform aims to revolutionize small molecule therapies, with our lead program, RAP-219, targeting focal epilepsy, neuropathic pain, and bipolar disorder. The company culture, driven by its 'Rapptors,' emphasizes science, mission, and teamwork, aiming to improve patients' lives through innovation and core values. This high-visibility Associate Director role serves as the DSPV Operations Lead, playing a critical, strategic, and hands-on operational part in supporting pharmacovigilance across all clinical development programs.

Requirements

Degree in Life Sciences, Pharmacy, Nursing or related field
8+ years of experience in PV in Biotech, Pharma, or a CRO
5 years of experience working with and providing oversight to PV vendors and/or hosting partners
Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER)
Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance
Effective collaboration and interpersonal skills
Ability to work independently, establish work priorities, and execute decisions with minimal guidance
Excellent decision-making and analytical skills

Responsibilities

Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing 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, and PVAs
Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement