Safety Surveillance Advisor I

Job Title: Safety Surveillance Advisor I
Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN

Department: Global Safety - Global Business Services (GS-GBS)

About the Position:
As a Safety Surveillance Advisor I, you will play a crucial role in establishing the product safety profile during development and maintaining the labeling for marketed products. Your responsibilities will include ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases, based on safety information from worldwide sources. You will communicate drug safety issues internally and to health authorities (HAs) as required. Additionally, you will establish, operate, and chair the NN cross-functional safety committee throughout the lifecycle of the actual product, presenting analysis and results of ongoing safety surveillance at predefined intervals for the safety committee's endorsement/recommendations. You will also be responsible for all areas related to patient safety in clinical trials.

Responsibilities:

• Act as the owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products and participate as a labelling change request (LCR) reviewer.
• Prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs).
• Respond to requests from HAs and internally from NN affiliates.
• Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), integrated safety summaries, abstracts, and planned publications.
• Provide proactive safety communication by participating in project/trial groups/teams established, as appropriate, and conducting Investigator training as required.
• Provide answers to inquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs).

Qualifications:

• Preferred: Masters in Medicine/MD post MBBS graduate.
• Relevant Experience in Signal Management, Aggregate Management, ICSR.
• Proficient in Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
• Fluent in written and spoken English.
• Analytical mindset with a quality mindset and organizational skills.
• Proactive planner with strong communication skills (verbal and written).
• Curious and constantly looking for improvement opportunities.
• Team player with high flexibility and service-mindedness.
• Cross-cultural awareness with the ability and willingness to quickly adjust to changes.

About the Department:
Global Safety - Global Business Services (GS-GBS) was established in 2010 as one of the hubs for safety case processing. GS-GBS handles case processing from different sources including spontaneous, literature, solicited, and clinical trials. The department is engaged in safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, signal detection activities, risk mitigation activities, training coordination, and literature surveillance activities, including medical literature monitoring.

About Novo Nordisk:
Novo Nordisk is a leading global healthcare company committed to defeating serious chronic diseases. With a legacy of over 100 years, Novo Nordisk impacts more than 40 million patient lives daily. Recognizing the importance of diversity, Novo Nordisk fosters an inclusive culture that celebrates the unique skills and perspectives of its more than 63,000 employees worldwide. Together, Novo Nordisk employees work toward a collective goal of making life-changing advancements in healthcare.

Contact:
To submit your application, please upload your CV and motivational letter online.

Deadline:
13th May, 2024.

Diversity and Inclusion:
Novo Nordisk is committed to creating an inclusive culture that celebrates the diversity of its employees, the patients it serves, and the communities it operates in. Together, Novo Nordisk aims to be the best company for the world, fostering a culture of inclusivity and equality.