Pharmacovigilance Associate II Job at Teva Pharmaceutical Industries Ltd., Delaware State

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  • Teva Pharmaceutical Industries Ltd.
  • Delaware State

Job Description

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Responsible for performing pharmacovigilance activities within the North America PV unit, in collaboration with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Directors to receive and review adverse event information for pre-marketing and post-marketing products. 

Liaise 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 accordance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure they are updated as required by regulations.  

How you’ll spend your day

  • Responsible for the receipt of adverse event information, including XMLs extraction, upload and receipt.
  • Performs case registration of adverse event reports by entering search information.
  • Responsible for submitting adverse event information to licensed partners within the required timeframe as per the pharmacovigilance agreement.
  • Responsible for collecting additional information from reporters and following up with healthcare professionals and consumers.
  • Review and assessment of the reportability of the adverse event to FDA or Health Canada, as appropriate.
  • Responsible for receiving, reviewing and performing all necessary actions related to negative acknowledgements to FDA and Health Canada, as appropriate.

Pharmacovigilance QMS

PhV Reconciliation

Your experience and qualifications

- Bachelor of Science degree with a major in a life science (e.g., pharmacy, physiology, biochemistry, anatomy, pharmacology, microbiology) at least
- 3 to 5 years experience in health or pharmaceutical sector and at least 2 years of experience in Pharmacovigilance
- Advanced English
- MS Word, MS Excel, MS Powerpoint, MS Outlook. Knowledge of computer systems such as Veeva Vault, ArisG, Argus and Cognos is a plus.
- Comfort with PV IT systems and familiarity with Veeva Vault security database and medical terminology. 
- Knowledge of related FDA/Health Canada and international regulations.

Reports To

Sr Manager Pharmacovigilance

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Job Tags

Local area,

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