Medical Safety Lead

Key Responsibilities • Monitors the clinical safety of projects/products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety-related questions appropriately.

• Performs medical assessment and related activities for single cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Of note: medical review of single case reports may need to be performed by Medical Safety Leads as required according to business needs.
• Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals based on single cases and aggregate data using proper signal detection tools.
• May support the GPSL and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL.
• Prepares medical input to aggregate clinical safety regulatory reports.
• Provides safety inputs for clinical and regulatory deliverables including clinical study protocols, clinical study reports, and investigator brochure. Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
• Role Requirements :
• Medical Degree (MBBS or MD) with MCI registrations required. Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
• Relevant experience (e.g., clinical, postdoctoral) after graduation.
• At least 8 years in drug development in a major pharmaceutical company, including 8 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
• Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports
• involving safety information • Experience with (safety or others) issue management.