Senior PV Physician I

Join to apply for the Senior PV Physician I role at PrimeVigilance.

Company Description

PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved global organic growth year after year, with staff based across Europe, North America, and Asia covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance provides first‑class support to pharmaceutical and biotechnology partners, covering all therapy areas including medical devices. We focus on employee training, development, well‑being, and mental health to promote a healthy work‑life balance, fostering high‑quality client service.

Job Description

The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of Individual Case Safety Reports (ICSRs), writing and/or reviewing signal detection reports, aggregate reports (DSURs, PSURs, PBRERs, PADERS), and Risk Management Plans (RMPs). The role also includes mentoring junior PV physicians and supporting the Qualified Person Pharmacovigilance (QPPV) in medical aspects and safety issues as required by Company or Client.

Responsibilities

• Review and approve post‑marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment, including coding, seriousness assessment, list/expectedness, causality, and writing company comments.
• Complete the adverse event tracker for all ICSR reports.
• Act as a Qualified Person for Pharmacovigilance or support the QPPV in the medical evaluation of safety issues.
• Review and approve literature screening search strategy and article relevance to safety findings.
• Collaborate on preparation of and input into Risk Management Plans.
• Assist in preparing responses to regulatory authority requests.
• Act as EEA QPPV and/or Deputy for up to 2 clients if required.
• Review and provide input on Periodic Safety Update Reports, Development Safety Update Reports, ACOs, and Annual Safety Reports.
• Lead medical input in specific pharmacovigilance areas such as Company Core Data Sheets.
• Participate actively in the Drug Safety Review Committee and advisory/scientific committees.
• Support preparation of PV procedures and provide training and mentoring to junior PV physicians.
• Offer medical advice to project teams daily and contribute to company‑level procedure development.

Qualifications

• Medically qualified physician.
• Previous experience in pharmacovigilance.
• Ability to review aggregate report types including PBRERs and DSURs.
• Expertise in signal detection activities.
• Excellent interpersonal and communication skills.
• Proficiency in planning, organizing, prioritizing, and executing multiple tasks.
• Cross‑cultural and cross‑functional collaboration skills.
• Advanced English (spoken and written).
• Advanced proficiency with MS Office.

Why PrimeVigilance

We prioritize diversity, equity, and inclusion, fostering a human‑centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow. We believe a human‑first approach strengthens our success in improving lives.

We Offer

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues worldwide, with English as the company language.

Core Values

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

Additional Information

• Seniority level: Mid‑Senior level

• Employment type: Full‑time

• Job function: Health Care Provider

• Industry: Pharmaceutical Manufacturing

Location: Warsaw, Mazowieckie, Poland.