Teva Pharmacovigilance Associate 

Mexico, Mexico City, Mexico City 

154756198

- 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 postmarketed products- Review and confirm that accurate written records of all PV related activities are created, organized and maintained
in compliance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions
(WIs) and ensure that they are up to date as required by regulations

-Assist and co-ordinate in the preparation of Risk Management Plans (with associated Risk
Mitigation Strategies) as per the requirement of Health Canada.
- Responsible for handling local labelling updates (from the CCSI update to submission of
safety variation) for all Teva medicinal products taking into consideration local regulatory
timelines.
- Review and submit Periodic Safety Update Reports (PSURs) and the Canadian Annual
Summary Report (ASRs) to Health Canada according to their regulations and guidance.
- Oversight of ADR reports downloaded from the Health Canada Vigilance Adverse Reaction
Online Database and to ensure all Health Canada requirements are met.
- Assist and co-ordinate in preparation of Health Hazard Assessment on request.
- Other essential duties include drafting pharmacovigilance agendas and meeting minutes,
accurately archiving pharmacovigilance documents
- Participate in Pharmacovigilance audits and inspections as needed
- Contributes to process improvements and assist with CAPA review.
- Responsible to complete all training and SOP/WI reviews in a timely manner
- Creates and/or updates SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient
- Support the manager in training new hires in PV on systems and processes relating to pharmacovigilance activities
-Participates in Pharmacovigilance local activities with case and workflow management
- Interfaces with other departments to facilitate information exchange as needed
- Responsible for leading local/regional projects when assigned
- Any other activities assigned by the Manager.

Bachelors of Science (Physics, Chemistry,
Biology, Biochemistry, microbiology, physiology,
Minimum 5 years of Health Care or
Pharmaceutical industry experience and at least
3 years of Pharmacovigilance experience
Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PV IT
systems such as Arisg, Argus, Cognos is an added advantage
Comfort with PV IT systems and a familiarity with the ARISg safety database and medical terminology.
In depth knowledge of the related FDA/Health Canada and international regulations

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