Apply on Employer Site

Rapport Therapeutics · 1 day ago

Associate Director, Drug Safety and Pharmacovigilance Operations

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$170K/yr - $185K/yr

8+ years exp

Rapport Therapeutics is driven by a passion for developing precision neuromedicines with the potential for fewer side effects. The Associate Director of Drug Safety and Pharmacovigilance Operations will play a critical role in supporting pharmacovigilance across all clinical development programs, ensuring compliance and operational excellence.

BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine

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

Qualification

PharmacovigilanceRegulatory complianceData managementVendor managementLife Sciences degreeFDA/EMA regulationsAggregate safety reportsAnalytical skillsCollaboration skillsDecision-making skills