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:
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.