Senior Pharmacovigilance Physician

Ergomed Group; Barcelona; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Pharmacovigilance Physician to oversee medical reviews and signal detection reports. This pivotal role involves mentoring junior physicians, contributing to risk management plans, and ensuring compliance with regulatory authority requests. As a key member of the team, you will support the Qualified Person for Pharmacovigilance and lead in specific areas requiring medical expertise. Join this innovative firm to make a significant impact in drug safety and patient health.

Formación

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

Responsabilidades

• Review and approve post-marketing ICSRs and SAE reports.
• Contribute to preparation of Risk Management Plans and regulatory responses.
• Lead in pharmacovigilance areas requiring medical input.

Conocimientos

Pharmacovigilance

Medical Review

Signal Detection

Risk Management

Mentoring

Educación

Medical Degree

Specialization in Pharmacovigilance

Descripción del empleo

Job Description

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

Responsibilities for the Client

1. Review and approve post-marketing ICSRs and SAE reports, including coding, seriousness assessment, listedness/expectedness, causality, and documentation such as trackers.
2. Complete adverse event trackers for all ICSRs reports.
3. Support the Qualified Person for Pharmacovigilance in medical understanding and evaluation of safety issues.
4. Review literature screening search strategies and articles for ICSRs/SAEs related to the medicinal product or safety findings.
5. Contribute to the preparation of Risk Management Plans and responses to regulatory authority requests.
6. Act as EEA QPPV and/or Deputy for up to two clients if required.
7. Review and provide input on Periodic Safety Update Reports, Development Safety Update Reports, and Annual Safety Reports.
8. Lead in specific pharmacovigilance areas requiring medical input, such as reference safety information.
9. Participate in the Drug Safety Review Committee, signal detection, and risk evaluation processes.

Additional Responsibilities for the Company

• Support PV procedures development and provide training and mentoring to junior PV Physicians.
• Offer medical advice to project teams daily and support the development of company-level procedures.
• Support the Director of Projects and QPPV, including training and mentoring on signaling activities.