Senior Pharmacovigilance Professional, Aggregate Reports

0-1 years

Not Disclosed

Zagreb

10 Nov. 30, 2024

Job Description

Job Type: Full Time Education: MBBS/MD/BVSc/DVM/BDS/DDS/BPharm/PharmD/B.Sc/M.Sc. 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: Senior Pharmacovigilance Professional, Aggregate Reports

Location: Zagreb, Croatia, 10000
Company: Teva Pharmaceuticals
Job ID: 59383
Date: Nov 21, 2024

About Teva Pharmaceuticals

Teva Pharmaceuticals is a global leader in the manufacture of generic medicines, dedicated to improving health and making it more affordable and accessible worldwide. With a presence in nearly 60 countries, Teva serves around 200 million people daily, offering a wide variety of essential medicines, including many on the World Health Organization's Essential Medicines List.

The Opportunity

Teva is seeking a Senior Pharmacovigilance Professional to join the team responsible for aggregate report preparation. This role focuses on ensuring operational excellence within the Periodic Reports unit and maintaining quality in line with regulatory requirements, particularly in the preparation and distribution of Periodic Safety Update Reports (PSUR) and related activities.

Key Responsibilities

PSUR Planning and Coordination: Assist in the planning of Periodic Safety Update Reports (PSURs), including divestments and integrations.
Quality Control: Coordinate and perform quality control of PSUR distributions and assessments.
Compliance Monitoring: Participate in compliance monitoring activities to ensure adherence to relevant regulations.
Audit and Inspection Support: Contribute to preparation for inspections and audits related to aggregate reports.
Document Management: Author or contribute to the development of working procedure documents for aggregate reports.
Team Support: Handle and triage team mailboxes and other related administrative tasks.
Collaboration: Work closely with internal teams such as Local Safety Officers, Regulatory Affairs, and other functions within Teva.

Contract: Fixed-Term

Qualifications and Experience

Education: University degree in a bioscience field such as medicine, veterinary medicine, dentistry, pharmacy, medicinal biochemistry, or a similar discipline.
Experience: Experience in pharmacovigilance is a plus, but not required for this position.
Skills:
- Proficient in Microsoft Office applications.
- Strong organizational and communication skills.
Language: Fluent in English (both written and spoken).

What We Offer

Fixed-term contract in an established global pharmaceutical company.
Opportunity to contribute to important safety reports and gain valuable experience in pharmacovigilance processes.
A collaborative, supportive work environment within a diverse and inclusive workplace.

Teva Pharmaceuticals is an Equal Opportunity Employer, dedicated to providing equal employment opportunities regardless of age, race, creed, religion, gender, disability, sexual orientation, or other legally protected status. If you need accommodations during the application process, please let Teva know.

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Senior Pharmacovigilance Professional, Aggregate Reports

Job Description

Job Title: Senior Pharmacovigilance Professional, Aggregate Reports

About Teva Pharmaceuticals

The Opportunity

Key Responsibilities

Contract: Fixed-Term

Qualifications and Experience

What We Offer

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