Senior Pharmacovigilance Physician

TN Italy; Milano; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading company in pharmacovigilance is seeking a Senior PV Physician to oversee medical reviews, signal detection, and mentoring of junior staff. The role emphasizes quality, integrity, and collaboration, offering opportunities for professional growth in a supportive environment.

Servizi

Training Opportunities

Growth Opportunities

Supportive Environment

Competenze

• Experience in pharmacovigilance.
• Expertise in aggregate reports and signal detection.

Mansioni

• Responsible for medical review of ICSRs and writing signal detection reports.
• Mentoring junior PV Physicians and supporting QPPV in safety issues.

Conoscenze

Interpersonal Skills

Communication Skills

English

Formazione

Medical Qualification as a Physician

Strumenti

MS Office

Descrizione del lavoro

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Job Reference:

125aa2da81e3

Job Views:

2

Posted:

12.05.2025

Expiry Date:

26.06.2025

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Job Description:

The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS, PBRERs, PADERS), reviewing risk management reports (RMPs), and mentoring junior PV Physicians. The Senior PV Physician I also supports the QPPV in medical and safety issues as required by the company or client.

For the Client

• Review and approve post-marketing ICSRs and SAE reports for causality assessment, including coding, seriousness, listedness/expectedness, and causality, with proper documentation.
• Complete adverse event trackers for all ICSRs.
• Support or act as a Qualified Person for Pharmacovigilance in medical evaluation of safety issues.
• Review literature screening strategies and articles for safety data.
• Contribute to Risk Management Plans and regulatory responses.
• Potentially act as EEA QPPV or Deputy for up to 2 clients.
• Review Periodic Safety Update Reports, DSURs, ACOs, and Safety Reports.
• Lead safety information activities, such as reference safety data.
• Participate in Drug Safety Review Committees and advisory boards.

Signalling

• Participate in signal detection activities, review reports, and advise on benefit/risk assessments.
• Evaluate signals, propose actions, and support safety reporting.
• Assist PV Project Managers in planning and quality assurance of signalling activities.

For the Company

• Support PV procedures development and training.
• Mentor junior PV Physicians and provide medical advice to project teams.
• Support the development and refinement of company procedures.
• Assist the Director of Projects and QPPV in daily activities.

Qualifications include medical qualification as a physician, experience in pharmacovigilance, expertise in aggregate reports and signal detection, excellent interpersonal and communication skills, and proficiency in English and MS Office.

Additional Information

PrimeVigilance values diversity, equity, and inclusion, offering training, growth opportunities, and a supportive environment. Core values include quality, integrity, passion, agility, belonging, and collaboration. Join us to make a positive impact in patients' lives!