Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. 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. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
- 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
- Should serve as a liaison 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 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.
Education: Bachelors of Science (Physics, Chemistry,
Biology, Biochemistry, microbiology, physiology,
anatomy, pharmacology)
Experience:
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
Assoc Dir Canadian Local Safety Officer • PV Canada
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. 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. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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