|Job Description||Manager, Pharmacovigilance|
The Pharmacovigilance (PV) Manager will provide oversight of the serious adverse event (SAE) workflow, safety vendor management, assistance with SAE reconciliation and annual report preparation, and support for risk management activities.
- Oversight of SAE collection, processing, initial triage, and assessment of completeness, consistency and seriousness within established time frames and in compliance with global regulatory requirements
- Preparation and distribution of 7-day or 15-day expedited reports to Mirati team members, clinical research organizations (CROs), licensing partners, and investigator-sponsored trials (ISTs)
- Independently perform AE/SAE reconciliation with appropriate CRO data management personnel and Mirati team members as applicable
- Pull SAE listings from safety database for Medical Monitors and Clinical Scientists to perform monthly safety review
- Maintenance of PV SOPs and Work Instructions, working with Mirati Quality Assurance.
- Support preparation and distribution of IND Annual Reports/Development Safety Update Reports (DSURs)
- Support preparation and execution of safety data exchange agreements with licensing partners.
- Create and maintain workflow trackers, flow charts as needed
- Execution of searches in the drug safety database as needed
- Represent PV and Safety Risk Management Department as applicable
- Under the direction/review of senior PV staff, participate in other PV and Risk Management activities as necessary
- Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for managing and tracking of SAE reports
- Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines.
- Strong communication skills, to facilitate interactions with study site personnel to discuss SAEs and AESIs, and to resolve queries
- Competent in Microsoft Word, PowerPoint, Excel
- Strong attention to detail
- Ability to work independently
- Bachelor’s degree in science, or health care related field (preferred)
- At least 5 years’ experience in the pharmaceutical industry with at least 3 years in a drug safety/pharmacovigilance role
- Experience in aggregate safety analysis
- Relevant experience in the oncology therapeutic area, strongly preferred
- Management of CROs and interactions with other third-party clinical trial collaborators