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Post : Organon - Manager Pharmacovigilance & Regulatory Affairs
Job Description
• Manages India and neighboring countries Pharmacovigilance regulatory requirements for new products and throughout the life cycle of the products marketed by the company
• Good Knowledge of Drugs and Cosmetics rules 1945 and Clinical trial regulations 2019
• Dossier compilation of registration for new products and post approval changes of registered products throughout their life cycle marketed by the company
• Filing and liaison with the regulators for the assigned products
• Ensures meeting all compliance to local regulatory requirements also adhering to company policies and procedure
• Compliance to the labelling and art work regulatory and company requirements
• Adhere to all the company SOP's and Regulatory tools
Candidate Profile
Graduate / Post graduate in Pharmacy with 3 years or more working experience in Pharmacovigilance and regulatory Affairs in pharmaceutical company.
Additional Information
Experience : 3 years
Qualification : Graduate / Post graduate in Pharmacy
Location : Haryana (ANTELLIQ), Gurgaon, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance & Regulatory Affairs
End Date : 5th May, 2021
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