Company Info

Job Description

• Core member of the safety team and is responsible for performing pharmacovigilance activities within the North America PhV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post- marketed 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 PhV 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

• Responsible for triaging of adverse event information , including extraction, upload and triage of XMLs
• 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
• Participate in Pharmacovigilance audits and inspections as needed
• Responsible for drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes.

Qualifications

Bachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology)

Preferred:  Rph or RN or Degree in the field of Medicine or Pharmacy or Nursing or equivalent combination of education and related work experience

2-3 years of Health care or Pharmaceutical industry experience and at least 1 year of Pharmacovigilance experience

Comfort with PHV IT systems and a familiarity with the ARISg safety database and medical terminology

Knowledge of the related FDA/Health Canada and international regulations

Ability to prioritize, analyze, plan, implement, and adjust goals and  objectives to meet needs 

Function

Sub Function

Reports To

Director Pharmacovigilance

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