PV Officer
Remote · Bucharest, București, Romania
Job Summary
PV Officer role focusing on ICSR management within PrimeVigilance, including processing Individual Case Safety Reports, SAE/SUSAR management, reconciliation, data protection, MedDRA/WHO coding, and collaboration with Medical Information, Regulatory Affairs, and Quality Assurance. Responsibilities also include workflow management, mentoring of junior staff, and supporting PV processes for clients; potential involvement with Local Contact Person for Pharmacovigilance (LCPPV) and Local Screening (PRLS) as agreed with line manager. Requires life sciences background or healthcare qualification and 2–3 years in pharmacovigilance, with strong communication, organizational, delegation, planning, time management, and team-working skills.
Required Qualifications
- 2-3 years of work experience in pharmacovigilance
- Life science graduate or pharmacy/nursing/healthcare qualification or experience in pharmacovigilance
- Excellent written and verbal communication skills
- Organization skills, attention to detail, multitasking
- Delegation skills
- Planning and time management
- Teamwork and collaboration
- Technical skills relevant to PV processes
- Mentoring/training of junior staff
- Familiarity with ICSR processing and related regulatory timelines
- Support of PV processes including local screen responsibilities (LCPPV) and local language roles (PRLS)
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