Pharmacovigilance Job at Novo Nordisk
A unique opportunity has arisen for a pharmacovigilance job at Novo Nordisk in Bangalore, Karnataka. This role is pivotal for those passionate about ensuring patient safety and contributing to the development of innovative therapies in the healthcare sector. Candidates with a background in medical jobs in India are encouraged to explore this position.
About Novo Nordisk:
Novo Nordisk Global Business Services (GBS) is a leading global healthcare company specialising in diabetes care, obesity, and rare diseases. With a commitment to improving patient outcomes, Novo Nordisk operates in over 80 countries and collaborates closely with various global hubs. The organisation is dedicated to advancing medical science and developing transformative therapies that enhance the quality of life for patients worldwide. This pharmacovigilance job plays a crucial role in shaping the safety profile of medicines that reach millions of patients globally.
Job Details:
- Category: Reg Affairs & Safety Pharmacovigilance
- Location: Bangalore, Karnataka, IN
- Company: Novo Nordisk Global Business Services (GBS)
Job Description:
As a Safety Surveillance Adviser in Global Patient Safety (GPS), the successful candidate will be at the core of product safety. This role involves establishing safety profiles during development, maintaining labelling for marketed products, and conducting ongoing surveillance of Novo Nordisk products throughout their lifecycle. The position is integral to ensuring that safety standards are upheld and that patient safety is prioritised.
Key Responsibilities:
- Acting as Owner of the safety sections of labelling for the evolving Company Core Data Sheet (CCDS) for development products, maintaining labelling for marketed products, and providing safety input as a labelling change request (LCR) reviewer.
- Preparing relevant sections of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities.
- Establishing, operating, and chairing the Novo Nordisk cross-functional safety committee throughout the product lifecycle – presenting analysis and results of ongoing safety surveillance at pre-defined intervals for endorsements and recommendations.
- Providing safety input to Product Development Plans, Trial Outlines, Protocols, Clinical Trial Reports, Investigator’s Brochures, integrated safety summaries, abstracts, and planned publications.
- Responding to enquiries from Health Authorities and Ethics Committees regarding safety aspects of protocols and Patient Information/Informed Consent, and ensuring deliverables to and from Data Monitoring Committees.
- Delivering proactive safety communication through participation in project and trial teams, and conducting Investigator training as required.
Education & Qualifications Required for this Pharmacovigilance Job:
Applicants for the pharmacovigilance job should possess:
- A Master’s degree in Medicine/MD post MBBS is preferred, ensuring a solid foundation in medical knowledge necessary for the role.
- Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Report (ICSR) handling is crucial to effectively manage and interpret safety data.
Skills Required for this Pharmacovigilance Job:
To excel in this pharmacovigilance job, candidates should demonstrate:
- The ability and willingness to quickly adjust to changes in a continuously developing environment, showcasing adaptability and resilience.
- Proficiency in the Microsoft Office package (Outlook, Word, Excel, and PowerPoint) to efficiently manage documentation and communication tasks.
- Strong communication skills and fluency in English, with the capability to convey complex safety information clearly to diverse stakeholders, ensuring effective collaboration and understanding.
