Senior Drug Safety Physician — Pharmacovigilance Expert

R&D Partners; Warszawa; On-site; PLN 349,000 - 436,000; Full time

Job summary

R&D Partners is seeking a Pharmacovigilance expert to oversee medical safety evaluations across the product lifecycle. The role requires strong clinical judgment, regulatory safety submission experience, and cross-functional collaboration with regulatory, clinical, medical affairs, and quality teams.

The role also involves providing medical input to PSURs/RMPs and supporting QPPV collaboration, with a focus on global pharmacovigilance compliance and process improvements.

Qualifications

• Extensive pharmacovigilance experience with ICH/GVP guidelines.
• Proven ability to lead and develop cross-functional teams.
• Excellent written and verbal English communication.

Responsibilities

• Medical review of ICSRs from trials, post-marketing and literature.
• Lead signal detection, validation, and risk assessments.
• Prepare input for PSURs, RMPs, and safety documents.
• Collaborate with QPPV and Safety Specialist.
• Support regulatory safety submissions and inquiries.

Skills

Pharmacovigilance

Medical review

Regulatory knowledge

Cross-functional collaboration

Leadership

English proficiency

Job description

R&D Partners is seeking a Pharmacovigilance expert to oversee medical safety evaluations across the product lifecycle. The role requires strong clinical judgment, regulatory safety submission experience, and cross-functional collaboration with regulatory, clinical, medical affairs, and quality teams.

The role also involves providing medical input to PSURs/RMPs and supporting QPPV collaboration, with a focus on global pharmacovigilance compliance and process improvements.