Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B)
Post : QAPV Associate in Regulatory and Quality Department
Job Description
About the department
Novo Nordisk India Pharmacovigilance (PV) team is well established with a purpose of delivering customer services related to complaints handling and Patient safety such as reporting of customer complaints and safety reporting of observational studies to health authorities. In this role, QAPV Associate is also responsible for quality assurance of one or more corporate systems such as evaluation imported products and product release. The main purpose of our existence is to provide superior service to our stakeholders consistently and add value t the processes in terms of standardisation and efficiency.
The position
• As a Pharmacovigilance and Quality Associate, you will be responsible for Reporting Customer Complaints within the timelines and follow-up. You will handle all safety related information received on safety mailbox. Notify safety information/ SAE to health authority within the stipulated timelines in accordance to the applicable regulations.
• Your wll be responsible for reporting of Serious Adverse Events (SAE) of the observational studies to Global Safety. Reporting of safety information / SAEs to Malaysian health authority. Archive all the submissions made to the relevant stakeholders and acknowledgements.
• You will also manage the Periodic Safety Update Reports (PSUR) notification to the health authority as per the regulations and transit data evaluation and release of products.
• The position offers a unique possibility to work with pharmacovigilance and quality assurance in a global organisation and develop your skills within the department.
• The position requires significant insight into key pharmacovigilance processes, e.g. customers handling, SAE reporting timelines, manage PSUR notification to the health authority, maintain electronic repository of all the submissions and product release.
Candidate Profile
• B. Pharma/ M. Pharma
• Excellent communication skills in English and comfortable working with different departments
• Fresher or 1 to 2 years of experience in Pharmacovigilance activities
• Ready to join immediately
Additional Information
Qualification : B.Pharm, M.Pharma
Experience : 1-2 years
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory and Quality
End Date : 13th March, 2020
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