Organon Manager Pharmacovigilance & Regulatory Affairs Recruitment
Pharma candidates are encouraged to apply online at MSD. Organon Manager Pharmacovigilance & Regulatory Affairs Recruitment. Regulatory Affairs candidates apply for a manager position that is available at MSD. Check out all the details on Rasayanika.com
Job Title: Organon – Manager Pharmacovigilance & Regulatory Affairs
Location Haryana (ANTELLIQ), Gurgaon, India
Organon – Manager Pharmacovigilance & Regulatory Affairs
Our Regulatory Affairs / Pharmacovigilance team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
WHAT WILL YOU DO:
- 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
WHAT YOU MUST HAVE:
Graduate / Postgraduate in Pharmacy with 3 years or more working experience in Pharmacovigilance and Regulatory Affairs in a pharmaceutical company.
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