MSD Pharmacovigilance & Regulatory Affairs Job – Apply Online
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.
Job Title: Organon – Manager Pharmacovigilance & Regulatory Affairs
Location Haryana (ANTELLIQ), Gurgaon, India
Job Type Full Time
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 25%
Flexible Work Arrangements: Not Specified
Shift: 1st – Day
Valid Driving License: No
Hazardous Material(s): no
Number of Openings: 1
Requisition ID: R110465
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 labeling and artwork 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.
WHO WE ARE…
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
To be considered for this position, please visit our career site at www.msd.com/careers and search for <R98969>
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