TL-Medical Safety

Job Description:

Responsibilities

• Perform systematic medical safety review of individual case safety reports to ensure accurate assessment of seriousness causality and clinical relevance in alignment with internal standards and global regulatory expectations.
• Apply foundational knowledge of pharma research and development to interpret clinical trial data product labels and risk benefit profiles when evaluating reported adverse events and safety signals.
• Execute end to end case processing activities including medical evaluation narrative refinement coding verification and consistency checks to maintain high quality safety data within applicable systems.
• Conduct thorough verification of source documents and supporting clinical information to confirm case validity completeness and coherence while escalating unclear or conflicting data for clarification.
• Participate in routine safety review meetings by providing concise case level insights that support aggregate safety assessments risk mitigation strategies and regulatory submissions.
• Adhere strictly to established pharmacovigilance workflows and standard operating procedures to ensure timely case processing within agreed service levels and compliance with global health authority requirements.
• Collaborate with cross functional pharmacovigilance and safety operations teams to clarify medical details resolve data discrepancies and support continuous improvement of safety review practices.
• Maintain meticulous documentation of case handling decisions rationale and follow up actions to enable transparent audit trails and facilitate inspections or internal quality reviews.
• Utilize safety databases and relevant tools to retrieve analyze and update case information while ensuring accurate coding and classification of events products and medical history.
• Contribute to signal detection and risk evaluation activities by highlighting unusual patterns medically significant events or emerging trends observed during case review activities.
• Support hybrid work model expectations by coordinating effectively through digital collaboration platforms and maintaining consistent communication with team members during day shift operations.
• Advance patient safety outcomes by ensuring that each processed case supports reliable safety profiles which inform healthcare professionals regulators and internal stakeholders.
• Engage in continuous learning related to evolving pharmacovigilance regulations medical safety methodologies and product specific knowledge to strengthen the quality of case evaluations.

Qualification & Experience

• Possess academic background in life sciences pharmacy medicine or a related discipline that enables sound understanding of clinical concepts and therapeutic areas relevant to medical safety.
• Demonstrate practical experience or training in pharmacovigilance and safety operations with direct exposure to case processing workflows and medical review principles even at an entry level.