Teva Pharmaceuticals is hiring B. Pharma/ M. Pharma as a Pharmacovigilance Associate II – Apply Now

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Take the next step in your pharmaceutical career journey with Teva Pharmaceuticals! We’re thrilled to announce a fantastic opportunity for skilled professionals in Pharmacovigilance. Teva Pharmaceuticals is currently seeking talented individuals with B. Pharma or M. Pharma qualifications to join our team as Pharmacovigilance Associate II. If you’re passionate about ensuring the safety and efficacy of pharmaceutical products and eager to contribute to global health, this could be the ideal role for you. Don’t miss out on the chance to grow your career with a renowned industry leader like Teva Pharmaceuticals. Apply now and embark on a fulfilling career path!

Job Title: Pharmacovigilance Associate II

Educational Qualification: B. Pharma OR M. Pharma

Experience: 4+ Years of experience in PV Health Canada Submission

Roles and Responsibilities

  • Core member of the safety team and is responsible for performing pharmacovigilance activities within the North American PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialist and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post- marketed products
  • Assist and co-ordinate in the preparation of Risk Management Plans (with associated Risk Mitigation Strategies).
  • Responsible for handling relevant local labelling updates
  • Receive, assess and submit foreign safety risk communication to Health Canada as required by regulations
  • Review and submit Periodic Safety Update Reports (PSURs) and the Canadian Annual Summary Report (ASRs) to Health Canada.
  • Support, guide the ADR reports downloaded from the Health Canada Vigilance Adverse Reaction Online Database and to ensure all Health Canada requirements are met.
  • Participate in Pharmacovigilance audits and inspections as needed – Contributes to process improvements and assist with CAPA review.
  • Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required
  • Interfaces with other departments to facilitate information exchange and communicates information to ensure clear and consistent reporting
  • Assist in revising and updating the procedural documents
  • Responsible for triaging of adverse event information, including extraction, upload and triage of XMLs
  • Performs case registration of adverse event reports by entering searchable information and performing duplication checks
  • Responsible for sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement
  • Review and assessment of reportability of the adverse event to FDA/Health Canada as applicable
  • Responsible for receiving, reviewing and performing all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable
  • Perform other tasks and duties as assigned by the manager
Date of Job Posting Apr 17, 2024
Location Bangalore, India, 60052
Company Teva Pharmaceuticals
Job Id 55222
Apply Online Click Here


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