PhV Safety Physician - Medical Safety Unit Team

PhV Safety Physician - Medical Safety Unit Team

Teva

Bucharest, 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.

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

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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