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Pharmacovigilance Officer, Team Leader (Line Management Position)

0-2 years
Not Disclosed
10 Oct. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 Officer, Team Leader (Line Management Position)

Location:

Zagreb, Croatia

Employment Type:

Full-time

Department:

ICSR Management


Company Overview:

PrimeVigilance, part of the Ergomed Group, is a specialised mid-size pharmacovigilance service provider established in 2008. The company has staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in its field. The company invests in staff training and development and emphasizes work-life balance to foster high-quality client service.


Job Overview:

The Pharmacovigilance Officer, Team Leader, is responsible for overseeing ICSR management activities in line with regulatory requirements and client expectations. The role includes line management, mentoring, and supporting PV processes for both PrimeVigilance and clients.


Key Responsibilities:

ICSR & Safety Management:

  • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, company procedures, and client-specific requirements.

  • Perform ICSR follow-up and SAE/SUSAR management, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.

  • Conduct clinical and partner reconciliation.

  • Ensure personal data protection and handle Product Quality Complaints in coordination with Quality Assurance.

  • Interact with Medical Information for safety-related inquiries.

  • Perform MedDRA and WHO coding.

  • Generate database outputs and reports, including monthly client reporting.

Team Leadership & Mentoring:

  • Mentor and train new and junior staff within the department.

  • Manage workflow and resources efficiently.

  • Support and contribute as an ICSR Subject Matter Expert (SME).

PV Support & Compliance:

  • Support PV processes related to ICSR management for PrimeVigilance and clients.

  • Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated countries/languages, as agreed with line manager.

  • Support the RA & PV Network Department as required.


Qualifications:

  • Life science graduate, pharmacy, nursing, or other healthcare-related qualification, or equivalent pharmacovigilance experience.

  • Extensive ICSR experience, including mentoring and line management.

  • Excellent written and verbal communication skills.

  • Strong organizational skills, attention to detail, multitasking, delegation, and time management.

  • Team-working and technical proficiency.

  • Fluent in English (spoken and written).


Why PrimeVigilance:

  • Opportunities for internal training and career development.

  • Strong emphasis on personal and professional growth.

  • Friendly, supportive, international working environment.

  • Collaboration with colleagues worldwide, with English as the company language.

Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships