Bilingual Pharmacovigilance Associate

3 weeks ago

Toronto, Ontario, Canada Teva Canada Full time
Who we are 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.The opportunity

The Bilingual Pharmacovigilance Associate is a core member of the PV Compliance team and is responsible for performing pharmacovigilance activities within the North America PV unit specifically for Canada in both official languages (ENG & FR), in partnership with the Drug Safety unit and Manager of PV Quality Compliance and the Local Safety Officer (LSO). The Associate ensures timely completion of all activities associated with PV operations, and general compliance tasks. In this role, the Associate will serve as a liaison with other Teva business units and function as a resource to the team and 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

How you'll spend your day

Essential Duties & Responsibilities:

Pharmacovigilance QMS and Compliance:
Participate in Pharmacovigilance audits and inspections (internal and external as needed)
Responsible for drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes.
Support and contribute on the implementation of the CAPA plan.
Support and contribute to any process improvements that are discovered through CAPA completion.
Assist with CAPA record maintenance in TrackWise system.
Oversight of timely completion of all activities associated with Deviation Management, including CAPA and Root Cause Analysis from ICSR CAPAS and audit/inspection findings.
Responsible to complete all training and SOP/WI reviews in a timely manner
Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient
Responsible for translation of PV documents (i.e. Safety Information, source documents, training materials and other PV relevant documents) from French to English and vice versa, as required
Train all the new hires in PV on systems and processes relating to pharmacovigilance activities and present information/ training in Face-to-Face settings

Training and Agreements:
Assist in training of internal and external interfaces (e.g. 3rd party partners and vendors) on systems and processes related to PV activities.
Draft, negotiate and maintain Agreements for partners and service providers.
Ensure Agreements records are maintained within the TrackWise database.

PV Reconciliation:
Ensures reconciliations are completed for the relevant internal and external interfaces (e.g. 3rd party partners and vendors) including ICSR and non-ICSR records.
Case Intake, Review, Triage & Date Entry:
Support in triaging of adverse event information, including reconciliations, extraction, upload and triage of source documents.
Responsible for sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement (i.e. reconciliations)
Responsible for collecting additional information from reporters and performing follow-up with health care professionals and consumers
Review and assessment of reportability of the adverse event to FDA/Health Canada, as required

Your experience and qualifications
  • Bachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology). Preferred: Rph or Degree in the field of Medicine or Pharmacy or equivalent combination of education and related work experience.
  • Fluently bilingual in both English and French
  • 2-3 years of Health care or Pharmaceutical industry experience. Preferred: 1-2 years PV experience (co-op experience is relevant)
  • Proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat
  • Familiarity with medical terminology
  • Knowledge of the related FDA/Health Canada and international regulations
Already Working @TEVA?

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's Equal Employment Opportunity Commitment 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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