Job Detail in India

Location: Bangalore, India, 60052
Company: Teva Pharmaceuticals
Job Id: 55222
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
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
Your experience and qualifications
B.Pharm OR M.Pharm
4+ Years of experience in PV Health Cananda Submission
Reports To
Assoc Dir Canadian Local Safety Officer
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.