Director Pharmacovigilance Safety Physician

Date: Oct 30, 2024

Location:

Bucharest, Romania, 050713

Company: Teva Pharmaceuticals

Job Id: 56387

Who we are

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!

The opportunity

As a Director, Pharmacovigilance Safety Physician you will lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout the product lifecycle and provide comprehensive safety information to patients, prescribers, and regulators.

How you’ll spend your day

• Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products and non-assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety review/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).

• Review complex Health Hazard Assessments and Health Authority requests.

• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.

• Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.

• Represent PV in cross-functional Product Label Working Group. Conduct evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.

• Provide PV support and safety contributions to Health Authority submissions and responses. Represent safety during due diligence of products.

• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality, etc.) and external stakeholers (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products. Collaborate with other cross-functional teams to ensure execution of the safety strategy.

Your experience and qualifications

• Medical Doctor degree

• Clinical practice experience and/or epidemiological degree/training

• Experience working in pharmacovigilance and drug safety, as a safety physician minimum 5 years

• Proven ability to handle safety surveillance tasks and chair safety committee meetings

• Ability to serve as a subject matter expert

• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority

• Ability to work cross-functionally within a matrix / international team across multiple time-zones

• Oral and written fluency in English

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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.

EOE including disability/veteran