1+ months

Pharmacovigilance 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 III (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 into the Delta system. Enter searchable information and perform duplication checks
  • Triage adverse event information for seriousness
  • Send  adverse event information to license partners within the required timeline as per pharmacovigilance agreement
  • Collect additional information from reporters and perform follow-up with health care professionals
  • Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required
  • Lead complex projects, write project plans,  monitor, and execute
  • Review  foreign cases for labeling and distribution to FDA
  • Receive and review negative acknowledgments during the time of FDA distribution
  • Participate in the US Pharmacovigilance audits and inspections
  • Monitoring of the US drug safety mailbox
  • Draft and finalize CAPAs as needed for late submissions and non-compliance with internal processes
  • Must be well spoken, organized, possess critical thinking and sound judgment, with the ability to perform well under pressure. Must be able to represent the job description activities and procedures in interviews with auditors and health authority inspectors
  • Provide guidance and training for team members with junior staff; typically acts as a lead, coordinating the work of others with less experience on team
  • Responsible for the extraction, upload, and receipt of XMLs
  • Solves complex problems; takes a new perspective using existing solutions
  • Works autonomously within established procedures and practices
  • Must possess interpersonal, decision-making, and organizational skills and the ability to develop cooperative working relationships with all levels of staff
  • Quality traits of diplomacy, professionalism, tact, and arbitration are important
  • Must be a team player; possess excellent communication skills with a high degree of overall poise, tact and courtesy; must be detail oriented and be willing to work in a hectic paced environment with time-sensitive materials
Qualifications

Required:

Bachelor of Science Degree or Bachelor of Science in Nursing or RPh (Registered Pharmacist)

 

Preferred:

Master of Science in Nursing or PharmD or equivalent combination of education and related work experience.

 

Required:

5 + years of Healthcare or pharmaceutical industry experience and at least 3 years of Pharmacovigilance (PHV) experience

Proficient with Microsoft Office, Excel, PowerPoint and Adobe Acrobat.

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

Function
Regulatory Affairs
Sub Function
Pharmacovigilance
Reports To

Director, Head of US PhV 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: 2019-10-07 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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Pharmacovigilance Associate

Teva Pharmaceuticals
Parsippany, NJ 07054

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