only medics  recruitment ltd

Senior Director Pharmacovigilance

Location
San Francisco
Salary
Competitive
Posted
25 Oct 2018
Closes
14 Feb 2019
Ref
JO-1810-418732

Fast growing Oncology-focused biopharmaceutical company is looking for a senior director of Pharmacovigilance in South San Francisco, CA. The Companys pipeline includes cancer immunotherapies against clinically-validated targets.

Reporting to the Vice President Clinical Development, the Senior director, Pharmacovigilance, is responsible for building and leading the safety and pharmacovigilance efforts for the clinical development department. The successful candidate works on abstract problems across clinical programs and identifies and evaluates fundamental clinical issues by assessing intangible variables


Job Duties:
Own the Clinical Safety strategy for all (four biologics in phase I/II and future pipeline compounds including T-cell bispecific Prodbodies) development compounds through phase I and II of development and CytomXs registrational programs
Oversee implementation of safety signal detection and introduce new concepts of signal detection as the safety database grows, including platform specific signal detection
Efficiently maintain adverse events and all other safety information in order to predict and manage the safety profile of compounds in clinical development (i.e. identify necessary updates to reference safety information and drive risk management initiatives according to global regulatory requirements)
Translate safety findings from pre-clinical toxicology studies into recommendations for safety monitoring for first-in-human studies
Requirements:
MD board certified internist or equivalent with 5+ years of safety/clinical development experience in the biopharma industry. Development experience with anti-cancer agents a plus
Experience with safety databases (i.e. Argus) and safety coding dictionaries (i.e. MedRA, WHODRUG)


Outstanding opportunity, please call Ashley Fiorelli at 617-844-1439 or email CVs to Ashley.fiorelli@cplphysicians.com

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