Pharmacovigilance Job at Novo Nordisk
A rare chance has emerged for aspiring Safety Surveillance Advisers at Novo Nordisk Global Business Services in Bangalore, Karnataka. This Pharmacovigilance Job focuses on enhancing the safety profile of medicines that impact millions of patients globally, with applications open until the specified deadline. Candidates looking to make a significant impact in global healthcare will find this non-clinical opportunity both challenging and rewarding.
About Novo Nordisk Global Business Services:
Novo Nordisk Global Business Services (GBS) is a leading global healthcare company that specializes in innovative treatments for chronic diseases. With a commitment to improving patient outcomes, Novo Nordisk operates in various therapeutic areas, including diabetes, obesity, and rare diseases. The organization is headquartered in Denmark and has a significant presence in Bangalore, India, where it drives research and development initiatives. Their work is centered around providing cutting-edge solutions and treatments that meet the needs of patients worldwide.
Job Details:
- Category: Reg Affairs & Safety Pharmacovigilance
- Job Name: Safety Surveillance Adviser I
- 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 play a pivotal role in product safety. Responsibilities include establishing safety profiles during development, maintaining labelling for marketed products, and conducting ongoing surveillance of Novo Nordisk products across their entire lifecycle. The role demands a high level of expertise and dedication to ensure that safety measures are thoroughly implemented and adhered to at all stages.
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.
Eligibility Criteria for this Pharmacovigilance Job:
- A Master’s degree in Medicine/MD post MBBS (preferred).
- Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Report (ICSR) handling.
- Ability and willingness to quickly adjust to changes in a continuously developing environment.
- Comfortable use of the Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
- Strong communication skills and fluency in English, with the ability to convey complex safety information clearly to diverse stakeholders.
Skills Required for this Pharmacovigilance Job:
- Strong analytical skills and attention to detail, enabling thorough evaluation of safety data.
- Ability to work independently as well as collaboratively in a team setting, fostering a cooperative work environment.
- Proficiency in data analysis and interpretation, essential for making informed safety decisions.
- Experience with safety databases and pharmacovigilance software, crucial for effective safety monitoring.
- Excellent organizational and time management skills, ensuring timely completion of safety-related tasks.
