Pharmacovigilance Associate II
Ciudad De Mexico, Mexico, 03810
Who we are
The opportunity
Responsible for performing pharmacovigilance activities within the North America PV unit, in collaboration with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Directors to receive and review adverse event information for pre-marketing and post-marketing products.
Liaise with other Teva business units and function as a resource to the team.
Review and confirm that accurate written records of all PV related activities are created, organized and maintained in accordance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure they are updated as required by regulations.
How you’ll spend your day
- Responsible for the receipt of adverse event information, including XMLs extraction, upload and receipt.
- Performs case registration of adverse event reports by entering search information.
- Responsible for submitting adverse event information to licensed partners within the required timeframe as per the pharmacovigilance agreement.
- Responsible for collecting additional information from reporters and following up with healthcare professionals and consumers.
- Review and assessment of the reportability of the adverse event to FDA or Health Canada, as appropriate.
- Responsible for receiving, reviewing and performing all necessary actions related to negative acknowledgements to FDA and Health Canada, as appropriate.
Pharmacovigilance QMS
PhV Reconciliation
Your experience and qualifications
- Bachelor of Science degree with a major in a life science (e.g., pharmacy, physiology, biochemistry, anatomy, pharmacology, microbiology) at least
- 3 to 5 years experience in health or pharmaceutical sector and at least 2 years of experience in Pharmacovigilance
- Advanced English
- MS Word, MS Excel, MS Powerpoint, MS Outlook. Knowledge of computer systems such as Veeva Vault, ArisG, Argus and Cognos is a plus.
- Comfort with PV IT systems and familiarity with Veeva Vault security database and medical terminology.
- Knowledge of related FDA/Health Canada and international regulations.
Reports To
Sr Manager Pharmacovigilance
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