AD/ Director, Pharmacovigilance Safety Science (remote)
Do you want to work with a rapidly expanding Oncology company? Do you want to work remotely post-COVID? If you answered yes to those questions, then you will be very interested in the clinical stage biotech company we have just partnered with that is searching for an AD/ Director, Pharmacovigilance Safety Science. This position is newly created, and this company has a very promising pipeline with a plethora of indications from pre-clinical to phase 2. As a testament to this organization's promise, this company has forged corporate partnerships with 3 highly successful large pharma companies. If interested in learning more do not hesitate to apply!
The AD/ Director, Pharmacovigilance Safety Science (remote) will be responsible for:
- Manage the signal management process (i.e., signal detection, tracking, review meetings) for assigned product(s) and evaluates safety data as part of ongoing pharmacovigilance activities.
- Includes synthesis of data from multiple sources and finalizing signal evaluation reports
- Support as key analytic and safety support lead in close collaboration with the heads of medical, clinical and regulatory.
- Support safety related activities for clinical trials, including but not limited to review of protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure, and clinical study reports
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Support DMC activities as applicable
- Represents PV as member of cross-functional clinical study management teams for assigned products
- Leads aggregate report management including strategy, review and finalization of aggregate safety reports for assigned products such as PADERs, PBRERs, and DSURs and demonstrates effective leadership skills with cross-functional partners to ensure aggregate reports are of high quality and submitted according to required timelines
- Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents. Responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative
- Develop pharmacovigilance plans and review of data across clinical partnerships and collaborations
- Contribute to the CDP throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimize the benefit/risk profile
- Accountable for the safety components of study reports, aggregate reports and high-level regulatory documents
- Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
- Enable/facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.
- Must be able to work closely and share responsibilities with Safety Operations and vendor management
Ideal Candidates will have:
- M.D. (or foreign equivalent), PhD, or a background in nursing with significant industry experience.
- Minimum 3-4 years pharmacovigilance experience.
- Experience in signal detection and risk management.
- Experience in Oncology.