Pharmacovigilance Associate II

Tevapharm; Ciudad de México; Presencial; USD 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company is seeking a Pharmacovigilance Specialist to manage adverse event information and ensure compliance with regulations. The role involves collaboration with various teams, documentation of activities, and assessment of reportability to regulatory bodies. Candidates should have a Bachelor’s degree in life sciences and relevant experience in the pharmaceutical sector.

Formación

• 3 to 5 years in the health or pharmaceutical sector.
• At least 2 years in Pharmacovigilance.
• Comfort with PV IT systems.

Responsabilidades

• Review adverse event information for pre-marketing and post-marketing products.
• Register adverse event cases and submit data to licensed partners.
• Assess reportability of adverse events to FDA or Health Canada.

Conocimientos

Proficiency in English

MS Word

Excel

PowerPoint

Outlook

Familiarity with Veeva Vault

Familiarity with ArisG

Familiarity with Argus

Familiarity with Cognos

Knowledge of medical terminology

Educación

Bachelor of Science in a life science

Descripción del empleo

The opportunity

Responsible for performing pharmacovigilance activities within the North America PV unit, collaborating with Drug Safety Specialists and Pharmacovigilance Managers/Directors to review adverse event information for pre-marketing and post-marketing products.

Liaise with other Teva business units and serve as a resource to the team.

Ensure all PV-related activities are accurately documented, organized, and maintained according to global and local SOPs and WIs, with updates as required by regulations.

How you’ll spend your day

• Receive adverse event information, including XML extraction, upload, and receipt.
• Register adverse event cases by entering search information.
• Submit adverse event data to licensed partners within required timeframes per pharmacovigilance agreements.
• Gather additional information from reporters and follow up with healthcare professionals and consumers.
• Assess the reportability of adverse events to FDA or Health Canada as appropriate.
• Handle negative acknowledgements from FDA and Health Canada as needed.

Your experience and qualifications

- Bachelor of Science in a life science (e.g., pharmacy, physiology, biochemistry, anatomy, pharmacology, microbiology).

- 3 to 5 years in the health or pharmaceutical sector, with at least 2 years in Pharmacovigilance.

- Proficiency in English.

- Skills in MS Word, Excel, PowerPoint, Outlook; familiarity with Veeva Vault, ArisG, Argus, Cognos is a plus.

- Comfort with PV IT systems and knowledge of medical terminology.

- Understanding of FDA/Health Canada and international regulations.

Reports To

Senior Manager, Pharmacovigilance