Teva Pharmacovigilance Associate II 

Mexico, Mexico City, Mexico City 

486924265

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.

• 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

- 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.

Sr Manager Pharmacovigilance

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