Senior Pharmacovigilance Specialist (Hybrid)

Merck Sharp & Dohme Corp.; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck Gruppe - MSD Sharp & Dohme in Warszawa is seeking a Senior Specialist, Drug Safety to develop and maintain PV processes ensuring high-quality case processing and regulatory reporting. You will collaborate with internal and external stakeholders to stay compliant with global PV regulations for drugs, vaccines, biologics and devices.

The role leads ICSR lifecycle activities, supports SDLC governance, and drafts safety management plans while guiding teams to improve PV compliance and

Qualifications

• Bachelor's or Master’s degree in life science/healthcare/pharmaceutical field.
• At least two years of pharmacovigilance safety experience or related areas.
• Strong knowledge of pharmacovigilance principles with attention to detail.

Responsibilities

• Lead in development of PV processes to ensure quality case processing and reporting.
• Provide guidance on PV activities and supervise ICSR lifecycle tasks.
• Support PV system development to stay compliant with requirements.
• Draft and maintain PV agreements and safety management plans.
• Identify and prioritize PV agreements to maintain regulatory compliance.

Skills

Adverse Event Reporting

Regulatory Compliance

Pharmacovigilance

Data Analysis

Quality Assurance

Risk Management

Process Improvement

Education

Bachelor’s degree in life science/healthcare/pharmaceutical field

Master’s degree in life science/healthcare/pharmaceutical field

Job description

Merck Gruppe - MSD Sharp & Dohme in Warszawa is seeking a Senior Specialist, Drug Safety to develop and maintain PV processes ensuring high-quality case processing and regulatory reporting. You will collaborate with internal and external stakeholders to stay compliant with global PV regulations for drugs, vaccines, biologics and devices.

The role leads ICSR lifecycle activities, supports SDLC governance, and drafts safety management plans while guiding teams to improve PV compliance and