5 days old

Pharmacovigilance Safety Physician

Parsippany, NJ 07054
  • Jobs Rated
    102nd

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!

 

R&D:
Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

 

 

Job Description

Your new position will report to Sr Dir Pharmacovigilance Safety Physician Team Lead, Medical Scientific Unit - US

 

  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments
  • Lead safety management for clinical development programs assigned including Company Sponsored, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with other functional groups to contribute to overall study execution while ensuring safety strategy and operational excellence
  • Contribute to clinical documents (e.g. protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety related clinical documents
  • Lead the Product Safety Group for each branded/innovative  product; participating in relevant safety board or DSMB
  • Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans
  • Lead ADR determination for label in the submission document and participate in label review and revision; key member for safety related label negotiation with regulatory agency
  • Oversee and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities. Represent PV position to different committees
  • Perform due diligence and Support PhV operations
  • PV Lead to support global launch activities for assigned products
  • Perform medical review of ICSRs for all products

Qualifications

Years of experience:

5 plus  years of years working as a safety physician in pharmaceutical companies

Education:
MD (US or other countries)

 

Experience:

  • Support Legal Department in safety related issues
  • Guide the scientists regarding the surveillance activities including medical review, signal detection and risk evaluation activities; provide support, training and continued improvement as appropriate
  • Manage decisions and actions to be taken, including communication to appropriate interfaces (e.g., Product Teams, Management, Affiliates and Regulators)
  • Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, QA etc) and outside Teva (KOLs, Universities etc

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

Reports To

In process of validation

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 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. 
 

 

Categories

Jobs Rated Reports for Physician

Posted: 2021-04-06 Expires: 2021-05-06

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 Safety Physician

Teva Pharmaceuticals
Parsippany, NJ 07054

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