Shilpa Medicare – Trainee Pharmacovigilance Jobs in Hyderabad 2021

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Shilpa medicare Limited Looking for Pharmacovigilance Professionals for their Unit 7 Hyderabad

Job Description :-

Department :- Pharmacovigilance

Position :- Trainee to Assistant manager

Education Qualification :-
Pharma D/M. Pharmacy (Pharmacology)

Experience :- 1-5 years

Work Location :- Hyderabad

Job Description :-

  • Candidate with good academic background will be considered. Essential function The Drug Safety Associate will provide technical and process-related support to drug safety management (post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
  • Key Accountabilities ? Handling of Individual Case Safety Reports (ICSRs) ? Weekly scientific literature monitoring in Literature Database ? Medical Literature Monitoring in EudraVigilance Database ? Daily Monitoring of EudraVigilance ICSRs ? Safety monitoring from regulatory authority websites and regulatory communications.
  • Preparation/ Review of Periodic Safety Update Reports (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER) ? Preparation/ review of Periodic Adverse Drug Experience Reports (PADER) ? Preparation/ Review of Risk Management Plan ? Maintenance of Signal Detection Calendar and Signal(s) Management Process ? Supporting to compliance activities Handling of Regulatory Approvals and Licensing information.
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Address :- Shilpa Medicare Limited Unit IV, R4HJ+M5Q, Ambatapur, Telangana 509301, India