Pharmacovigilance Associate

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. 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.

The opportunity

Core member of the safety team responsible for performing pharmacovigilance activities within the North America PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post-marketed products.

Your experience and qualifications

1. Bachelor of Science in Physics, Chemistry, Biology, Biochemistry, Microbiology, Physiology, Anatomy, or Pharmacology.
2. 1-3 years of global experience in the pharmaceutical industry or CRO experience, with at least 1 year of Pharmacovigilance experience.
3. Proficiency with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat. Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage.
4. Demonstrated teamwork, critical thinking, and good communication skills.

How you’ll spend your day

1. Intake of adverse event information, including extraction, upload, and intake of XMLs.
2. Perform case registration of adverse event reports by entering searchable information.
3. Send adverse event information to in-license partners within the required timeline as per pharmacovigilance agreement.
4. Collect additional information from reporters and perform follow-up with healthcare professionals and consumers.
5. Review and assess reportability of the adverse event to FDA/Health Canada as applicable.
6. Receive, review, and perform all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable.
7. Participate in Pharmacovigilance audits and inspections as needed.
8. Draft and finalize CAPAs as needed for late submissions and non-compliance with internal processes.
9. Complete all training and SOP/WI reviews in a timely manner.
10. Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures.
11. Train all new hires in PhV on systems and processes relating to pharmacovigilance activities and present information/training in face-to-face settings.
12. Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements.
13. Draft pharmacovigilance agendas and meeting minutes, accurately archive pharmacovigilance documents.

Reports To

PV Operations & Compliance Sr. Manager

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. 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.