Teva Bilingual Pharmacovigilance Associate 

Canada, Ontario, Toronto 

69622350

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

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 settingsAssist 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.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

• 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+ years of Health care or Pharmaceutical industry experience. Preferred: 1+ year 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

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