Require Deputy Local Pharmacovigilance Manager at Boehringer Ingelheim
Boehringer Ingelheim is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 23.1% of its net sales.
Post : Deputy Local Pharmacovigilance Manager
Job Description :
Manage & support the product safety surveillance for the OPU and dependant countries (if applicable) by establishing and maintaining a local pharmacovigilance system which fulfils compliance with internal procedures and external requirements (e.g. local and international regulation). Function as a back-up for LPVM in the absence of him/her.
Duties & Responsibilities:
• Ensure PV training in line with BI Corp PV SOPs.Ensure regular information and training of the PV staff in case of changed procedures or relevant pharmacovigilance related topic.
• Ensure PV information and training locally to Medical, Clinical Operations, Marketing and other targeted functions when deemed necessary (eg. Medical orientations, Updates on PV SOP, Adhoc PV topic).Ensure archival of all training materials
• Monitor compliance, quality and volume of processed and reported AE cases.Perform checks to ensure compliance and quality in PV in the OPU.Provide guidance for PV compliance and quality management in the OPU
• Check the drug safety section (proposal and report) on the studies in the OPU (clinical trial, PMS studies, NTA etc.Provide PV guidance on studies in the OPU and the necessary support to ensure that PV process is adequately implemented.Ensure continuous safety screening and local signal detection in the OPU.Provide the necessary PV support and guidance for the launch readiness and the PV post marketing activities.
• Knowledge of local and international pharmacovigilance regulation
• Excellent command of English language
• B Pharm. at least 6 years exp.
Experience : 6 year
Qualification : B.Pharm
Location : India
Industry Type : Pharma
Functional Area : Pharmacovigilance
End Date : 10th April, 2019
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