Global Program Safety Lead

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 accountabilities:

• 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) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Is 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.
• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
• Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members -Contributes to and often leads the development of departmental and functional/business unit goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key performance indicators:

• Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations & procedures -Compliance, consistency and quality of safety deliverables

Minimum Requirements:
Work Experience:

• People Challenges.
• Managing Crises.
• Collaborating across boundaries.
• Operations Management and Execution.
• People Leadership.

Skills:

• Clinical Research.
• Clinical Trials.
• Functional Teams.
• Leadership.
• Medical Strategy.
• Process Safety Management.
• Regulatory Compliance.
• Risk Management.
• Safety Science.

Languages :

• English.

 

Skills Desired

Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science