Pharmacovigilance Manager

4+ years

Not Disclosed

Sofia

10 April 18, 2025

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

Pharmacovigilance Manager

Date: 22nd March 2025
Location: Sofia, Bulgaria, 1407
Company: Teva Pharmaceuticals
Job ID: 58869

Who We Are:
As a global leader in generic medicines with a strong innovative portfolio, Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Alongside our established presence in generics, we invest heavily in research and development for innovative medicines, generic drugs, and biosimilars. Our portfolio of around 3,600 products benefits nearly 200 million people in 60 countries every day.

In Bulgaria, Teva (previously known as Actavis until 2020) is the largest employer in the pharmaceutical sector, employing around 1700 people across two manufacturing plants (Dupnitsa and Troyan), a sales and marketing organization, and various global corporate functions.

Learn more at www.tevapharm.com and www.teva.bg.

The Opportunity:
We are looking for a qualified and motivated candidate for the role of Pharmacovigilance Manager, based in Sofia, Bulgaria. The primary responsibility of this role is to establish and maintain a domestic Pharmacovigilance (PV) unit and manage all PV activities as per Global/Regional PV SOPs/WIs, in collaboration with global and regional teams as well as local commercial management.

How You’ll Spend Your Day:

Act as the contact point with local health authorities for safety matters regarding Teva's products.
Establish and maintain working relationships with local departments and external contractual parties related to PV.
Ensure that all Teva Bulgaria employees are familiar with PV obligations and activities are performed to required standards.
Implement out-of-office hours, back-up, and business continuity arrangements for local PV activities.
Collect and process Adverse Events/Adverse Drug Reactions (AEs/ADRs) and Special Situations from all sources in compliance with regulations.
Perform local literature searches in addition to Global literature searches.
Collaborate with local Regulatory Affairs for Periodic Safety Update Reports (PSUR) and Company Core Safety Information (CCSI).
Maintain awareness of all studies and organized data collection schemes conducted in Bulgaria.
Ensure all necessary PV activities and risk minimization measures related to Risk Management Plans (RMPs) are executed.
Establish processes to manage PV-relevant commercial and service provider agreements.
Manage reconciliation and Corrective Action and Preventive Action (CAPA) processes.
Stay up-to-date with local and global regulatory requirements and document gap assessments.
Manage electronic PV records and ensure disaster recovery protocols are in place.

Your Experience and Qualifications:

University degree in Pharmacy, Medicine, or other relevant life science fields.
In-depth knowledge of European and Bulgarian pharmacovigilance requirements.
Minimum of 4 years of relevant experience in Pharmacovigilance.
Additional experience in Regulatory, Quality, or Clinical Trials is a plus.
Fluency in English and Bulgarian, both written and spoken.
Strong experience working with matrix teams and collaborating with global and local stakeholders.
Strong interpersonal and communication skills.
Ability to work independently on PV-related tasks.
Analytical abilities and a creative, solution-oriented approach.
Flexibility to work in a fast-paced, dynamic environment with tight deadlines.
Strategic thinking and strong ethical and scientific standards.

Enjoy a More Rewarding Choice:

Dynamic and challenging work environment at one of the world’s leading pharmaceutical companies.
Competitive remuneration linked to performance.
Additional healthcare insurance.
Transportation allowance.
Flexible working hours and work-from-home options per company policy.
Opportunities for professional development.

Make a Difference with Teva Pharmaceuticals:
If this opportunity sounds right for you, please send your CV in English. Only shortlisted applicants will be contacted. All personal data is protected by law and will be treated confidentially.

Already Working at Teva?:
If you are a current Teva employee, please apply through the internal career site via Employee Central for prioritized consideration.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to providing equal employment opportunities without regard to age, race, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, veteran status, national or ethnic origin, or any other legally protected status. We are dedicated to creating a diverse and inclusive workplace.

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