Manager – Phamacovigilance/ Drug Safety – Biocon Bengaluru
Manager of Phamacovigilance/ Drug Safety at Biocon, Bengaluru.
Biocon has a job opening for Manager Position in Phamacovigilance/ Drug Safety. Selected Candidate has to be the Key Contact with the external CRO’s / global licensing partners on issues of phamacovigilance; Review and overview of all safety data (both non-clinical and clinical); Review and/or sign off of protocols, SOP’s, clinical study reports, IBs, IMPD; Review safety data and participate in dose escalation decisions; Authorship and sign off of safety monitoring plan/ risk management plan; Lead data analysis and writing of regulatory submission document for license application and variation activities and for safety issues and questions from regulators; Direct the setup of safety procedures and development of safety exchange agreements; Perform activities required to serve as a PV physician; Review local cases for the designated products; Periodic medical literature search and review, trend analysis and signal generation and establish and maintain a network with all licensing and business partners for coordination reporting; Provide case management and maintain phamacovigilance and drug safety operation as well as conduct medical assessment, determine additional information needed and independently generate drug safety; Guide crisis management on drug safety and define process for drug recall.
Who can Apply?
- MD in Pharmacology with 6-10 yrs of experience in Phamacovigilance or Drug Safety.
- Experience in Contract Research Organization or Pharmaceutical / Biotechnology Company.
- In-depth clinical background and good knowledge of EMEA, Non-EU and FDA regulation.
- Strong knowledge of worldwide safety regulation for marketed and investigational products.
- Industrial knowledge and experience in drug safety and phamacovigilance and FDA and global regulations related to drug safety reporting, ICH guidelines, GCP and the process required to comply.
How to Apply?
Contact:
Arvind Padmanabhan
Biocon Limited
20th KM Hosur Road Electronic City
Bengaluru – 560100.
Ph: 91-80-28082216
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