What are the responsibilities and job description for the Associate Director, Pharmacovigilance Operations position at Priovant Therapeutics?
Overview
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Associate Director, Pharmacovigilance Operations will help advance this mission by leading the operational aspects of Priovant's pharmacovigilance efforts across late-stage programs.
Responsibilities
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Associate Director, Pharmacovigilance Operations will help advance this mission by leading the operational aspects of Priovant's pharmacovigilance efforts across late-stage programs.
Responsibilities
- Oversee day-to-day pharmacovigilance (PV) operations in collaboration with external CRO partners, including case processing, reporting, and event reconciliation
- Responsible for safety operational content and processes for clinical trials and future post-marketing activities such as CRFs, safety management plans, SAE forms, pregnancy forms; tools and processes for safety database requirements and configurations to enable safety-related activities during studies; training requirements and materials for clinical trial safety report collection
- Prepare data for retrieval and analysis, which may include querying the safety database, preparing data for interpretation, and review of data output to support signal detection, risk management and other safety data review activities
- Develop, implement, and ensure maintenance of operational processes and safety management plans to support clinical development and future post-marketing activities
- Ensure timely processing and reporting of individual case safety reports (ICSRs) and expedited safety reports
- Support Data Monitoring and Clinical Endpoint Committee activities by providing requisite safety information
- Retrieve, prepare, and analyze data for to support inquiries from regulatory agencies, IRB/ECs, and other stakeholders
- Provide required input to and review aggregate reports (e.g. DSUR) and other applicable regulatory documents
- Support literature reviews, identify background population rates, and summarize relevant findings to support safety surveillance, regulatory reporting, and other stakeholder documents
- Oversee the CRO submission process for safety reporting
- Support clinical trial safety report collection and collaborate with other functions (e.g., clinical Operations, Data Management, Regulatory, Biostatistics) to ensure consistency with regulations and study objectives. Utilize the Safety and EDC database for clinical case review and basic queries
- Oversee review and archive of PV-related records in various documentation management systems (e.g. TMF)
- Provide analysis of relevant regulatory agency (FDA/EMA) guidelines governing pharmacovigilance activity for clinical trial and post-marketing settings
- Provide support to Clinical Operations and Quality organizations for monitoring and audit / inspections purposes.
- Oversee vendor performance and execute and monitor compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans
- 5 years of pharmacovigilance operations experience
- Degree in a scientific or healthcare-related field
- Experience with global development programs, including phase 3 pivotal trials
- Experience in a small biotech or working on a small cross-functional team preferred
- Proven track record of supporting successful NDA and/or BLA submissions preferred
- Experience with PSURs/DSURs, patient narratives, and/or authoring other safety related documents preferred
- Experience with signal detection and risk management preferred
- Therapeutic area experience in immunology and autoimmune diseases preferred
- Familiarity with FDA and international adverse event reporting regulations
- Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
- Exceptional organizational and project management skills with the ability to handle multiple priorities
- Hands-on, roll-up-your-sleeves, proactive approach, with a high sense of urgency and drive for results
- Demonstrated communication, problem-solving, and decision-making skills
- Natural collaborator who enjoys working on a cross-functional team
