Safety Surveillance Adviser I - Novo Nordisk (Bangalore, India)
Job Category:
Regulatory Affairs & Safety Pharmacovigilance
Location:
Bangalore, India
About the Position:
The Safety Surveillance Adviser will play a key role in establishing the product safety profile during development and maintaining the labelling for marketed products. The role involves continuous surveillance of Novo Nordisk (NN) products during both pre-approval and post-approval phases, gathering safety information globally and communicating issues to health authorities and internally. The individual will chair the NN cross-functional safety committee and communicate safety findings to drive actionable recommendations.
Key Responsibilities:
Take ownership of safety sections for evolving Company Core Data Sheets (CCDS) for development products.
Maintain labelling for marketed products and participate in labelling change request (LCR) reviews.
Prepare Development Safety Update Reports (DSURs), Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).
Provide safety input to Product Development Plans (PDP), Trial Outlines, Clinical Trial Reports, Investigator’s Brochures (IB), and other safety documents.
Participate in project teams and conduct Investigator training.
Respond to safety-related enquiries from Health Authorities (HAs) and Ethics Committees (ECs).
Manage deliverables with Data Monitoring Committees (DMCs).
Qualifications:
Education: Masters in Medicine/MD post MBBS is preferred.
Experience: Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSR).
Skills: Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint), analytical mindset, excellent communication skills (written and verbal), and the ability to manage multiple priorities.
Additional: Strong quality focus, proactive planner, team player, and flexible in a dynamic environment.
About the Department:
Global Safety - Global Business Services (GS-GBS) handles safety case processing from various sources, including spontaneous reports, literature, solicited reports, and clinical trials. GS-GBS is involved in safety report submissions, quality control, signal detection, and risk mitigation activities.
Working at Novo Nordisk:
Novo Nordisk is a global leader in healthcare, with a strong legacy in diabetes care. The company is committed to driving change to defeat serious chronic diseases and impact patient lives. Novo Nordisk values the skills and perspectives of its 63,000 employees and works toward creating a diverse and inclusive culture.
Application Process:
To apply, please upload your CV and motivational letter online. Internal candidates must inform their line manager before applying.
Deadline for Applications:
April 20, 2025.
Disclaimer:
Beware of fraudulent job offers. Novo Nordisk does not extend unsolicited job offers or charge fees during the recruitment process.
Commitment to Diversity:
Novo Nordisk is committed to an inclusive recruitment process and recognizes the importance of diverse perspectives in building a strong, collaborative team.
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