Pharmacovigilance Officer, Team Leader (Line Management position)

Company Description

PrimeVigilance, part of Ergomed Group, is a specialised mid‑size pharmacovigilance service provider established in 2008. The company has achieved organic global growth year after year and employs staff across Europe, North America and Asia, covering services in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first‑class support to pharmaceutical and biotechnology partners, fostering long‑lasting relationships and maintaining a focus on employee training, well‑being, and a healthy work‑life balance.

Job Description

• Provide support to project‑team activities on behalf of the client and the company.
• Perform ICSR management unit activities within agreed deadlines, including processing Individual Case Safety Reports (ICSRs) from all sources, following up on ICSR timelines, and handling follow‑up work.
• Manage SAE/SUSAR activities such as unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review.
• Reconcile clinical and partner data as required.
• Ensure personal data protection compliance.
• Handle Product Quality Complaints and collaborate with Quality Assurance.
• Support Medical Information interactions.
• Perform MedDRA and WHO coding for reports.
• Create database outputs and monthly reports for clients.
• Manage workflow and resource allocation.
• Mentor and train new and junior employees within the department.
• Support PV processes related to ICSR management for both PrimeVigilance and clients.
• Act as ICSR SME and contribute to cross‑functional teams.
• Assist the RA & PV Network Department as needed, including acting as the Local Contact Person for Pharmacovigilance (LCPPV) for the specified country and the Person Responsible for Local Screening (PRLS) for the designated language, as agreed with the line manager.

Qualifications

• Life science graduate; pharmacy, nursing or other healthcare‑related qualification, or proven experience in pharmacovigilance.
• Extensive ICSR experience, including mentoring and leading reports.
• Excellent written and verbal communication skills.
• Strong organisational skills with attention to detail and the ability to multitask.
• Delegation, planning and time‑management capabilities.
• Technical proficiency relevant to the role.
• Team‑working attitude.
• Fluent in English (spoken and written).

Additional Information

PrimeVigilance prioritises diversity, equity and inclusion, creating an equal‑opportunity workplace where people of all cultural backgrounds, genders and ages can grow. We believe a human‑first approach and collaboration are key to our success and to improving patient lives.

We Offer

• Internal training and career development opportunities.
• Strong emphasis on personal and professional growth.
• A friendly, supportive working environment.
• Opportunity to collaborate with colleagues worldwide, with English as the company language.

Core Values

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Legal

Industry: Pharmaceutical Manufacturing

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