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.
Post : Pharmacovigilance Associate in Regulatory and Quality Department
• As a Pharmacovigilance Associate, you will work on reporting customer complaints to global safety within the timelines. Handling of all the safety related information emails received on safety mailbox.
• You will be responsible for reporting the safety information/sever adverse events to the health authority & investigators and team within the stipulated timelines and in accordance to the applicable regulations and procedures.
• Supporting the team in archiving all the submissions made to the relevant stakeholders and acknowledgements in the study specific files and drug product specific files.
• You will be responsible for maintaining the electronic repository of all the submissions and acknowledgements and maintain the tracker.
• You will manage the Periodic Safety Update Report (PSUR) notification to the health authority as per the regulations.
• Bachelor’s or Master’s degree in Pharmacy
• 0-2 years of Pharmacovigilance related experience
• Knowledge of Indian Drug Regulations
• Highly proactive and able to take initiatives
• Ability to solve highly complex tasks
Qualification : M.Pharm, B.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory and Quality Department
End Date : 20th September, 2020
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