8 days old

Senior Drug Safety Associate

Parsippany, NJ 07054
Company Info
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!
Job Description

The Pharmacovigilance Associate II (Drug Safety Associate) is a core member of the Safety Team and is responsible for performing pharmacovigilance activities within the US Pharmacovigilance (PhV) unit.

In partnership with the Drug Safety Specialists and Pharmacovigilance Managers, this position functions to receive and review adverse event information for pre and post- marketed products.  This position will serve as a liaison with other Teva business units and function as a resource to the team.

  • Performs case registration of adverse event reports by entering searchable information and performing duplication checks
  • Responsible for triaging of adverse event information
  • Sends adverse event information to in license partners within the required timeline as per pharmacovigilance agreement
  • Collects additional information from reporters and performs follow-up with health care professionals and consumers
  • Perform daily, weekly, and/or monthly reconciliations of adverse event reports as required
  • Receives and reviews negative acknowledgments during the time of FDA distribution
  • Participates in the US Pharmacovigilance audits and inspections as needed
  • Responsible for drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes
  • Responsible to complete all training and SOP/WI reviews in a timely manner
  • Responsible for the extraction, upload, and triage of XMLs
Qualifications
  • Bachelors Degree required.  RPh preferred (Registered Pharmacist)
  • 3 + years of Healthcare or pharmaceutical industry experience and at least 2 year of PHV experience
  • Comfort with PHV IT systems and a familiarity with the ARISg safety database
  • Demonstrates proficiency with Microsoft Office, Excel, PowerPoint
Function
Regulatory Affairs
Sub Function
Pharmacovigilance
Reports To

Director, Head of US Pharmacovigilance and Local Safety Officer

Tevas 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.

Categories

Posted: 2019-11-05 Expires: 2019-12-05

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Drug Safety Associate

Teva Pharmaceuticals
Parsippany, NJ 07054

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