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Senior Manager, Drug Safety

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Taro in USA
 
Senior Manager Drug Safety
 
Execute U.S. Adverse Event and pharmacovigilance activities as required by FDA regulations. Coordinate Adverse Event and pharmacovigilance activities for Taro sites worldwide. Provide support and oversight in related Drug Safety activities including Product Quality Complaints and Medical Information activities. Participate in review of PV related legal agreements. Assist as an SME for PV audits of affiliates and vendors. Represent U.S. Taro Drug Safety during FDA inspections. Manage U.S. Drug Safety staff, including work distribution and performance evaluations.
 
Requirements:
 
Medical degree (M.D.) or Doctor of Pharmacy (PharmD), foreign educ. equiv. acceptable, and minimum 4 years of managerial experience in the pharmaceutical industry with complete familiarity with FDA and ICH regulations and guidelines related to Adverse Events, Drug Safety and Pharmacovigilance practices. Extensive familiarity with key tools such as MedDRA, MedWatch and Periodic Adverse Event reporting formats is required. Travel required for participation in FDA conferences, PV audits and global meetings with Taro affiliates.
 
PLEASE NOTE: ALL JOB OPPORTUNITIES ARE ELIGIBLE FOR INCENTIVES OFFERED UNDER THE EMPLOYEE REFERRAL PROGRAM
 
Submit Resumes Via Email Only to: Susanne.Foulds@Taro.com. Please include salary requirements. Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Drive, Hawthorne, NY 10532.