Job Description Summary
-Designs & develops safety surveillance strategy for products and approval. Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

Job Description
Major Responsibilities:
- Provides expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
- Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.




- Develops and is responsible for key internal Novartis safety documents reviews these documents regularly and updates as required (e.g. when significant current information received). Ensures that these, and all other project-related safety documents, are consistent in safety messages.
- Owns the safety strategy and document it in the corresponding documents (e.g. dSPP, SSPT) and leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products.
- Responsible for overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team (SMT). Ensures that this team appropriately and timely reviews all medical safety data from various sources (e.g., pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process.
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📌 Director, Global Program Safety Lead (Hyderabad)
🏢 Novartis
📍 Hyderabad