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Pharmacovigilance Manager

2+ years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Pharmacovigilance Manager

Location: Istanbul, Turkey
Company: Teva Pharmaceuticals
Job ID: 59205
Date: Nov 13, 2024


About Teva Pharmaceuticals

Teva’s mission is to make healthcare more affordable and accessible to people around the world. We’re a leading global manufacturer of generic medicines and are proud to produce many of the products on the World Health Organization’s Essential Medicines List. With 200 million people relying on Teva products daily, we continue to seek innovative ways to make a difference in healthcare.


The Opportunity

As a Pharmacovigilance Manager, you will be responsible for monitoring and evaluating the safety of Teva products, ensuring compliance with global pharmacovigilance regulations and internal policies. Your role will be pivotal in managing safety reports and collaborating with cross-functional teams to ensure the timely and accurate reporting of adverse events to regulatory authorities.


Key Responsibilities

  • Safety Monitoring: Monitor and assess the safety information for Teva products, ensuring full compliance with global pharmacovigilance regulations.

  • Safety Reports & Documentation: Handle the submission and documentation of safety reports, including PSURs (Periodic Safety Update Reports), CCSI (Company Core Safety Information), RMPs (Risk Management Plans), and other regulatory safety documents.

  • Cross-functional Collaboration: Work closely with internal teams to facilitate the timely reporting of adverse events to regulatory bodies.

  • Process Development & SOPs: Develop, implement, and maintain processes and SOPs (Standard Operating Procedures) to ensure compliance with pharmacovigilance guidelines.

  • Internal Support: Provide guidance to internal teams on safety requirements, pharmacovigilance processes, and best practices.

  • External Communication: Act as the main point of contact for external partners, including regulatory agencies, on drug safety concerns.

  • Risk Management: Contribute to the development and maintenance of risk management plans and safety-related documents for Teva products.

  • Regulatory Updates: Stay updated with changes in pharmacovigilance regulations, and implement necessary updates to internal processes.

  • Audits & Inspections: Participate in audits and inspections related to pharmacovigilance activities, ensuring compliance with all applicable standards.

  • Training & Mentoring: Train and mentor new members of the drug safety team, ensuring they are supported and have the expertise they need.

  • Cross-functional Projects: Engage in cross-functional initiatives aimed at improving and optimizing drug safety processes.

  • Documentation: Maintain accurate and comprehensive documentation of all drug safety activities, ensuring compliance with company and regulatory standards.


Qualifications & Experience

  • Education: Bachelor's degree in Life Sciences, Pharmacy, or a related field.

  • Experience:

    • 2+ years in drug safety, pharmacovigilance, or related fields within the pharmaceutical industry.

    • Strong understanding of local pharmacovigilance regulations and guidelines.

    • Experience in safety data review and adverse event analysis.

  • Skills:

    • Excellent communication and interpersonal skills, with the ability to collaborate across teams and with external partners.

    • Strong analytical skills, attention to detail, and the ability to interpret complex safety data.

    • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with pharmacovigilance systems.


Why Teva?

  • Global Impact: Work for a company that impacts the lives of 200 million people every day.

  • Career Growth: Develop your career within a leading pharmaceutical company committed to professional growth and learning.

  • Diverse & Inclusive Culture: Teva fosters a diverse, inclusive environment where everyone is encouraged to contribute their best work.


Teva Pharmaceuticals is an Equal Opportunity Employer, committed to diversity and inclusion. If you require accommodations during the recruitment process, please inform us so we can support you in an accessible way.

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