Director Pharmacovigilance Safety Physician

5+ years

Not Disclosed

Bucharest

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: MD/PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director Pharmacovigilance Safety Physician
Location: Bucharest, Romania
Date Posted: December 27, 2024

Join Teva Pharmaceuticals, a global leader in healthcare dedicated to improving health and accessibility for millions worldwide. Our employees make a difference daily, delivering the world’s largest medicine portfolio to over 200 million people.

The Opportunity

As the Director, Pharmacovigilance Safety Physician, you will lead safety evaluation activities, risk mitigation, and safety communication for assigned products throughout their lifecycle. Your expertise will contribute to safeguarding patients and ensuring compliance with global safety standards.

Key Responsibilities

Safety Data Evaluation:
- Lead medical evaluation of aggregate safety data for assigned products.
- Perform activities such as signal detection, regulatory safety reports (e.g., PSUR, PADER, DSUR), and health hazard assessments.
Signal Management:
- Validate and author complex signal evaluations.
- Consolidate safety information from various sources to assess signals and risks.
Risk Management:
- Develop and maintain Risk Management Plans (RMPs) and additional risk minimization measures.
- Define safety-related risks and manage risk plans throughout product lifecycles.
Labeling Activities:
- Represent pharmacovigilance (PV) in cross-functional Product Label Working Groups.
- Evaluate and contribute to safety-related product labeling, including negotiations with regulatory agencies.
Regulatory Support:
- Provide PV input for Health Authority submissions and responses.
- Represent safety considerations during due diligence for products.
Cross-functional Collaboration:
- Partner with internal teams (e.g., Medical Affairs, Clinical Development, Quality).
- Engage external stakeholders (e.g., KOLs, CROs) to address safety concerns and develop safety strategies.

Qualifications and Experience

Education:
- Medical Doctor degree required.
- Training or experience in clinical practice or epidemiology.
Experience:
- Minimum 5 years as a safety physician in pharmacovigilance or drug safety.
- Expertise in safety surveillance and leading safety committee meetings.
Skills:
- Ability to serve as a subject matter expert in PV and safety.
- Strong interpersonal and communication skills to influence and collaborate across departments.
- Proven ability to work in cross-functional, international teams spanning multiple time zones.
Language:
- Oral and written fluency in English.

Reporting to: Associate VP or Senior Leadership in Pharmacovigilance (specific reporting line not mentioned).

Why Join Teva?

Collaborate with global teams and innovative minds.
Contribute to patient-centric health solutions.
Be part of a company with a rich legacy of improving global health.

Application Process for Current Teva Employees:
Apply through the Internal Career Site on "Employee Central" to access priority consideration and exclusive opportunities.

Equal Employment Opportunity:
Teva Pharmaceuticals is an equal opportunity employer, committed to creating a diverse and inclusive workplace. Accommodations are available throughout the recruitment process to ensure a fair experience for all candidates.

For further details, visit Teva Careers to start your journey toward making a global impact!

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Director Pharmacovigilance Safety Physician

Job Description

The Opportunity

Key Responsibilities

Qualifications and Experience

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