Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.
Post : Medical Safety Lead (Sandoz)
Job Description :
• Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs).
• Preparation/review of investigator notifications and periodic medical assessments for ethics committees. Medical review of single case reports according to business needs (example SUSARs)
• Review safety documents prepared by External Service Providers. Performs medical assessment of product quality defects with or without adverse events, including the review of line listings whenever required and proposes relevant market action.
• Monitoring and evaluation of all safety signals both from internal and external sources including literature sources, single cases and/or aggregate data and presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.
• Prepares safety responses to inquiries from regulatory authorities, health care professionals or legal queries on the benefit-risk balance of assigned products. Supports Country Organization and other stakeholders on safety related questions when global input is required.
• Depending on assigned products and portfolio, may support the GPSL/Medical Safety Group Lead 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.
• Lead/Review the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels.
• Provides guidance as appropriate to Case processing team for the coding and causality/expectedness assessment of adverse event reports as and when needed. Provides inputs and collaborates on preparation of Safety Profiling Plan (SPP)
• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) 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 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
• Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
• Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information
• Experience with (safety or others) issue management and decision making on safety topics.
Experience : 4 years
Qualification : M.Pharm, B.Pharm, M.Sc, PharmD, PhD or Masters in relevant field or Medical Degree (MBBS or MD)
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th April, 2023
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