Associate Principal Scientist, Medical Safety Review Physician

Join MSD Polska as an Associate Principal Scientist, Medical Safety Review Physician. Under the direction of the Associate Vice‑President, Head of ICMR and Senior Directors, you will conduct in‑line medical reviews of individual case safety reports (ICSRs) from company clinical trials and other sources, determine expedited reporting needs, perform medical assessments, provide causality statements, generate medical queries, ensure compliance with global expedited reporting timelines, perform Analysis of Similar Events (AOSE), participate in quality review of other MR physicians, lead cross‑functional projects, and contribute to continuous process improvement.

• Provide in‑line medical review of individual case safety reports as per SOP.
• Determine expedited reporting requirements and provide causality assessment.
• Improve accuracy and completeness of case reports via medical queries.
• Ensure compliance with global expedited reporting timelines.
• Perform AOSE when applicable under direction of MSR Director.
• Participate in quality review of ICSR from other MR physicians and associates.
• Lead or participate in cross‑functional projects as MSR subject‑matter expert.
• Consult with clinical directors and CSRM physicians for additional expertise.
• Participate in training of the specified MSR team.
• Participate in process, quality, innovation, technology and other business‑related activities.
• Participate in special projects or rotational assignments for professional development.

Required Skills

• Adaptability, Audit Process Evaluations, Case Report Forms, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Risk Management, Clinical Sciences, Communication, Compliance Program Development, Continual Improvement Process.
• Critical Thinking, Data Analysis, Decision Making, Detail‑Oriented, Drug Safety Surveillance, Ethical Compliance, Healthcare Risk Management.
• Medical Writing, Pharmacokinetics, Pharmacovigilance, Post Marketing Surveillance, Regulatory Communications, Regulatory Compliance Audits.

Preferred Skills

• Current Employees apply.
• Current Contingent Workers apply.

Employee Status

Regular

Relocation

None

Visa Sponsorship

None

Travel Requirements

None

Flexible Work Arrangements

Hybrid

Shift

None

Valid Driving License

None

Hazardous Material(s)

None

Job Posting End Date

11/14/2025

Requisition ID

R359088

Seniority level

Not Applicable

Employment type

Full‑time

Job function

Research, Quality Assurance, and Science

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services