Reference No: J25737

Head, Drug Safety and PharmacovigilanceA fast growing bio-tech focused on impacting the lives of patients with serious cardiometabolic lipid disorders. They require a Head of Drug Safety and Pharmacovigilance to drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics

Responsibilities

-All aspects of the Drug Safety and Pharmacovigilance function
-Quality, Operational and Compliance
-Review and approval of Safety-related submission documents:
-Clinical study reports
-Study protocols
-Clinical Trial (Serious) Adverse Event Reports
-Case files, narratives, coding, causality and expectedness assessment
-Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
-Support of study DSMBs by provision of requested Safety data and analyses
-Writing of safety section, including benefit risk assessment, of DSURs, annual reports, and RMPs
-Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)

Requirements
-Medical Degree (MD/DO), preferably board certified in internal medicine
-10+ years of experience in pharmacovigilance gained in pharmaceutical industry
-5+ years of management experience in Pharmacovigilance and/or Drug Safety
-A successful track record of high productivity and quality of work
-Proficiency in relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential.
-Working knowledge of MedDRA dictionary is necessary
-Familiarity with common Safety databases (e.g. ARIS, etc.) is preferred

For more details about this role and the company please email a resume to stuart.gilboy@cplphysicians.com

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