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    Pharmacovigilance Manager

    Teva Pharmaceuticals
    4+ years
    Not Disclosed
    Sofia
    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: Sofia, Bulgaria, 1407
    Company: Teva Pharmaceuticals
    Job ID: 58869
    Date: Nov 19, 2024

    About Teva Pharmaceuticals in Bulgaria

    Teva Pharmaceuticals, a global leader in generic medicines, is the largest employer in the pharmaceutical industry in Bulgaria. The company operates two manufacturing plants (in Dupnitsa and Troyan) and employs nearly 1700 people across its various functions. Teva's extensive product portfolio includes around 3,600 medicines and serves nearly 200 million people globally.

    The Opportunity

    Teva Pharmaceuticals is seeking a Pharmacovigilance Manager based in Sofia, Bulgaria, to establish and maintain a domestic Pharmacovigilance (PV) unit. This position will be responsible for overseeing all PV activities in line with Global/Regional PV Standard Operating Procedures (SOPs) and working closely with local and global teams. The role involves a range of responsibilities, including safety reporting, regulatory collaboration, and managing PV-related relationships with external stakeholders.

    Key Responsibilities

    • Safety Reporting: Collect and process Adverse Events (AEs) and Adverse Drug Reactions (ADRs) in compliance with local and regional regulations.
    • Health Authority Liaison: Serve as the primary contact point with local health authorities regarding the safety of Teva products.
    • Collaboration with Internal Teams: Establish strong working relationships with various Teva departments such as Regulatory Affairs (RA), Medical Affairs (MA), Quality Assurance (QA), and Sales & Marketing.
    • Employee Training: Ensure that Teva employees in Bulgaria are familiar with Pharmacovigilance obligations and that local PV activities are performed to the required standard.
    • Out-of-Hours Coverage: Establish backup and business continuity plans for PV activities, ensuring no disruption to safety reporting.
    • Literature Search: Conduct local literature searches in addition to global searches, ensuring thorough safety data collection.
    • Periodic Safety Updates: Collaborate with Regulatory Affairs to prepare and align Periodic Safety Update Reports (PSUR) and Company Core Safety Information (CCSI) for local renewals.
    • Risk Management Plans: Ensure timely implementation of Risk Management Plans (RMPs) and additional risk minimization activities required for local products.
    • Third-Party Agreements: Manage PV-relevant agreements with external service providers, ensuring vendor selection is conducted properly.
    • CAPA Management: Implement and manage Corrective and Preventive Actions (CAPA) where required.
    • Regulatory Compliance: Stay updated on relevant local and global pharmacovigilance regulations and ensure compliance with SOPs and legislation changes.
    • IT and PV Systems: Ensure that electronic records related to PV are properly stored and managed in accordance with local Disaster Recovery Plans (DRP).

    Qualifications & Experience

    • Education: University degree in Pharmacy, Medicine, or another life science relevant field.
    • Experience:
      • At least 4 years of relevant experience in Pharmacovigilance.
      • Knowledge of European and Bulgarian pharmacovigilance regulations is essential.
      • Additional experience in Regulatory Affairs, Quality, or Clinical Trials would be a plus.
    • Language Skills:
      • Fluency in English and Bulgarian (both written and spoken) is required.
    • Team Collaboration: Experience in working with matrix teams and coordinating with local and global stakeholders.
    • Communication Skills: Strong interpersonal and communication skills for working in cross-functional teams.
    • Independence: Ability to work independently on PV-related topics with a solution-oriented mindset.
    • Analytical Skills: Strong analytical abilities and the ability to think strategically in a fast-paced, changing environment.
    • Ethical Standards: High level of ethical integrity and scientific standards.

    What We Offer

    • Dynamic Work Environment: A challenging and rewarding role in one of the leading pharmaceutical companies globally and the largest in Bulgaria.
    • Competitive Compensation: Performance-based remuneration.
    • Benefits:
      • Additional healthcare insurance.
      • Transportation allowance.
      • Flexible working hours with options to work from home.
    • Career Development: Opportunities for growth and development within the organization.

    Teva Pharmaceuticals is an Equal Opportunity Employer, committed to creating an inclusive and diverse workplace. If you need accommodations during the recruitment process, please let us know.

    #LI-Hybrid

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