Bilingual Pharmacovigilance Associate

Date: Apr 4, 2023



Location: Toronto, Ontario, Canada, M1B2K9



Company: Teva Pharmaceuticals



Job Id: 47327

Who are we?

Teva is a global pharmaceutical leader and the world\'s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world\'s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we\'ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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). Ensures timely completion of all activities associated with PV operations, and general compliance tasks. 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 Essential Duties & Responsibilities: Case Intake, Review, Triage & Date Entry: Responsible for triaging of adverse event information, including extraction, upload and triage of source documents.
Performs case registration of adverse event reports by entering searchable information and performing duplication checks
Responsible for sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement
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 applicable
Pharmacovigilance QMS: 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
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.

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

Sub Function

Pharmacovigilance

Already Working @TEVA?

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Teva\xe2\x80\x99s 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.