Jobs Pharmacovigilance Associate Safety Operations Advisor at Novo Nordisk
- Opportunity as a Pharmacovigilance Associate Safety Operations Advisor at Novo Nordisk
- Position Overview
- About Global Safety at Novo Nordisk
- Key Responsibilities
- Qualifications and Skills
- Apply online
Opportunity as a Pharmacovigilance Associate Safety Operations Advisor at Novo Nordisk
Are you a motivated individual who thrives in challenging environments? Do you enjoy collaborating with key stakeholders to achieve strategic alignment? Are you eager to be part of a dynamic team that values continuous improvement? If so, we invite you to explore an exciting opportunity with Novo Nordisk. Join our team as a Pharmacovigilance Associate Safety Operations Advisor and contribute to our mission of making a positive impact on patients’ lives through innovative healthcare solutions.
Position Overview
Job Category: Clinical Development and Medical
Location: Bangalore, Karnataka, India
About Global Safety at Novo Nordisk
At Novo Nordisk, Global Safety in Bangalore plays a pivotal role in ensuring the safety and quality of our clinical development and marketed products. This department is responsible for global surveillance, handling, and reporting of adverse events reports. As a Pharmacovigilance Associate Safety Operations Advisor, you will contribute to maintaining high safety standards in our products and clinical practices.
Key Responsibilities
In this role, you will be responsible for a range of tasks that require professional insight, decision-making skills, and a collaborative approach. Your responsibilities will include:
- Ensuring compliance with global regulatory requirements for the collection, evaluation, and reporting of safety information on Novo Nordisk pharmaceutical products.
- Conducting medical evaluation and reporting of adverse events from clinical use of Novo Nordisk products in the post-approval phase.
- Timely reporting of serious adverse events associated with Novo Nordisk products to relevant authorities.
- Evaluating reports of serious adverse events and establishing possible causal relationships.
- Reviewing and preparing relevant follow-up questions, ensuring consistency in handling cases and coding.
- Collaborating with clinical project groups and safety meetings as needed, providing support for data management colleagues, and ensuring accurate and consistent coding of adverse events using MedDRA.
Qualifications and Skills
To excel in this role, you will need:
- A post-graduate MD/MBBS with relevant Pharmacovigilance experience.
- Documented scientific experience, preferably in the pharmaceutical industry (0 to 1 plus years of experience).
- Good knowledge of diseases, clinical manifestations, treatment, and complications.
- Strong understanding of clinical pharmacology.
- Proficiency in computers and databases.
- Fluent written and spoken English.
- Strong planning and coordination skills, along with accountability and initiative.
- The ability to work independently and collaboratively, manage projects, and communicate effectively with various stakeholders.
- A solid understanding of pharmacovigilance, clinical development, and regulatory requirements.