Senior PV Physician I

PrimeVigilance; Milano; In loco; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

A mid-size pharmacovigilance service provider in Italy is seeking a Senior PV Physician I responsible for medical review of safety reports, writing aggregate reports, and mentoring junior staff. Candidates should have a medical qualification and experience in pharmacovigilance. The company offers training opportunities, a supportive environment, and values work-life balance.

Servizi

Training and career development opportunities

Supportive work environment

Focus on diversity, equity, and inclusion

Work-life balance

Competenze

• Previous experience in pharmacovigilance.
• Experience reviewing aggregate report types including PBRERs and DSURs.

Mansioni

• Medical review of Individual Case Safety Reports and Serious Adverse Event reports.
• Writing and reviewing signal detection reports and aggregate reports.
• Reviewing risk management plans and providing medical input for regulatory responses.
• Mentoring junior PV physicians and supporting training programs.

Conoscenze

Signal detection expertise

Interpersonal skills

Communication skills

Organizational skills

Cross-cultural teamwork

Advanced English

MS Office literacy

Formazione

Medical qualification

Descrizione del lavoro

Senior PV Physician I

Company: PrimeVigilance (part of Ergomed Group)

PrimeVigilance is a mid‑size pharmacovigilance service provider established in 2008 with staff across Europe, North America and Asia. We provide medical information, pharmacovigilance, regulatory affairs and quality assurance services to pharmaceutical and biotechnology partners.

Job Description

The Senior Pharmacovigilance Physician I is responsible for:

• Medical review of Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, including coding, seriousness assessment, and causality evaluation.
• Writing and reviewing signal detection reports and aggregate reports such as DSURs, PSURs, PBRERs, PADERS.
• Reviewing risk management plans (RMPs) and providing medical input for regulatory responses.
• Acting as a Qualified Person for Pharmacovigilance or supporting the QPPV on medical aspects and safety issues.
• Mentoring junior PV physicians and supporting training programs.
• Participating in the Drug Safety Review Committee and other scientific advisory committees.
• Providing medical advice to project teams and supporting the preparation of PV procedures and signalling procedures.
• Supporting the QPPV and Director of Projects on day‑to‑day activities.

Responsibilities for the Client

• Review and approve post‑marketing safety reports and assess associated documentation.
• Complete adverse event trackers for all reports.
• Review literature screening strategies and study relevant safety publications.
• Provide input in risk management plans.
• Lead the preparation of regulatory authority responses.
• Act as EEA QPPV or Deputy for up to two clients.
• Review and contribute to periodic safety update reports, development safety update reports, ACOs, or annual safety reports.
• Lead in specific pharmacovigilance areas, such as creating reference safety information.

Qualifications

• Physician with medical qualification.
• Previous experience in pharmacovigilance.
• Experience reviewing aggregate report types including PBRERs and DSURs.
• Expertise in signal detection activities.
• Excellent interpersonal, communication and presentation skills.
• Strong organizational skills and ability to prioritise multiple tasks.
• Cross‑cultural and cross‑functional teamwork capability.
• Advanced English (spoken and written).
• Advanced literacy in MS Office.

Benefits and Culture

PrimeVigilance offers training and career development opportunities, a supportive work environment, and the chance to work with colleagues worldwide in English. We prioritize diversity, equity, and inclusion and value employee well‑being and work‑life balance.