Informacje o stanowisku

Pharmacovigilance Physician II - Endocrinology Experience

• Full-time
• Department: PV Medical Group

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to 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 our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.

We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment for high-quality client service.

Join us in this exciting journey to make a positive impact in patients’ lives.

The Senior Pharmacovigilance (PV) Physician II is responsible for:

1. Medical review of Individual Case Safety Reports (ICSRs), writing and reviewing signal detection reports, and aggregate reports (DSURs, PSURs/PBRERs/PADERS, ACOs, responses to regulatory authority requests).
2. Writing and/or reviewing risk management reports (RMPs) and mentoring junior PV Physicians.
3. Supporting the Qualified Person for Pharmacovigilance (QPPV) in medical aspects and safety issues as required.

Responsibilities for the Client:

• Review and approve post-marketing ICSR and Serious Adverse Event (SAE) reports for medical/causality assessment.
• Complete the adverse event tracker for all ICSR reports.
• Act as a Qualified Person for Pharmacovigilance or support the QPPV in medical understanding and evaluation of safety issues.
• Review literature screening search strategy and articles for ICSRs/SAEs related to the relevant medicinal product.
• Cooperate in the preparation of Risk Management Plans.
• Prepare responses to regulatory authority requests.
• Review and provide input in Periodic Safety Update Reports and other safety reports.
• Act as Company Lead in specific pharmacovigilance areas requiring medical input.
• Participate in Drug Safety Review Committee activities.

Signalling Responsibilities:

• Review line listings and participate in signal detection activities.
• Evaluate and categorize possible signals and propose a course of action.
• Support preparation and review of benefit-risk reports.
• Oversee the quality of signal detection activities.

Responsibilities for the Company:

• Support the preparation of PV procedures.
• Provide training and mentoring to junior PV Physicians.
• Provide medical advice and input to project teams daily.

The Senior PV Physician should be medically qualified with demonstrated experience in Pharmacovigilance and a clinical setting. Endocrinology experience is required.

Excellent interpersonal skills, ability to plan, organize, prioritize, and execute multiple tasks are essential.

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace. Our core values are key to how we operate:

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

We offer training and career development opportunities, a friendly working environment, and the opportunity to work with colleagues globally. Join us to make a positive impact in patients’ lives. We look forward to your application!

Warszawa - Oferty pracy w okolicznych lokalizacjach