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PhV Safety Physician - Medical Safety Unit Team, Romania

Date: Feb 18, 2021

Location: Bucharest, RO, 050713

Company: Teva Pharmaceuticals

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!

PhV Safety Physician - Medical Safety Unit Team, Romania

Teva Pharmacovigilance (Patient Safety) unit is hiring a PhV Safety Physician to join the Medical Scientific Unit. In this unit, we lead drug safety across the entire Teva portfolio and throughout the product lifecycle. 


Role: Safety Physician
Safety expert of the assigned product(s), establishing the safety strategy and direction in clinical development and in post marketing setting. The SP is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

Key Responsibilities:

• Offer global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs and risk management planning throughout the product lifecycle
• Ensure dedicated safety surveillance:
  - Lead risk management activities for assigned products globally
  - 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 within Teva (Medical Affairs, Clinical Development, QA etc.), and outside Teva (KOLs, Universities etc.)
• 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
• Lead the Product Safety Group meetings – in which safety strategies are discussed and decisions are taken (in both clinical trials and post marketing settings) regarding: protocols, CSRs, ISS, Developmental RMP/RMP, etc.
• Lead the safety parts/documents of dossier submissions. This includes generating the first label, RMP, clinical overview, REMS, answering the Health Authorities questions related to safety
• Build collaborative working relationships with other PhV safety physicians and development and brand teams globally to ensure full cooperation. Craft high quality medical evaluation of safety data for global regulatory purposes
  - Offer medical support for Global Patient Safety and Pharmacovigilance activities and reports within the department, as appropriate
  - Deliver medical input for review of Adverse Event cases
• Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of laws, regulations and guidance
• Support the Legal Department in safety related issues 
• Preparation of responses to regulatory inquiries on product safety issues and contribution to regulatory documents
• Take part in preparing & providing training to newcomers or other MSU members in different topics as required
 

The Ideal Candidate Should Have:

• A Medical Doctor with clinical practice of at least 2 years, specialized doctor will be a huge advantage
• 3 years of relevant experience in pharmaceutical industry (PhV, clinical development) – an advantage
• Must speak fluid English and be a proficient scientific / medical writer
• Competencies:
  - Leadership skills, strong ability of managing without authority
  - Analytical capabilities
  - Assertiveness
  - Teamwork skills
  - Excellent communication skills 
• Ability to work under pressure, sometimes with tight deadlines
• Good knowledge of Microsoft Office platforms 


We Offer:

• An exciting and challenging job in an innovative, flexible and growing company
• A team of young, hard-working, open-minded and friendly colleagues
• Trainings in Pharmacovigilance field
 

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

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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.