Vigilance Specialist - India

The role involves end-to-end complaint and incident management, coordination with global stakeholders, regulatory reporting to health authorities, and ensuring compliance with applicable vigilance regulations across markets.

Your key responsibilities will be:

*       Receiving, recording, evaluating, investigating, and processing of all complaints involving Rayner products that have been placed on the market.

*       Ensure smooth flow management of complaint cases to meet internal and regulatory timelines & communicate effectively with customers regarding complaints.

*       Perform medical and technical evaluation of reported events.

*       Ensure complete and accurate documentation in vigilance and complaint management systems.

*       Preparation of data relating to the vigilance system to be used in product risk management.

*       Preparation of data relating to the vigilance system to be used to support new and/or renewed global registrations.

*       Preparation of data relating to the vigilance system to be used in Clinical Evaluation Reports, Technical Files or other company required data packages.

*       Preparation of data relating to the vigilance system specific to direct markets to better aid the Commercial Team’s understanding of events in India and the ROW.

*       Submission of medical device incident reports to global regulatory authorities.

*       Ensure compliance to internal SOPS and external regulations/standards.

*       Support activities of the vigilance team to help ensure that all stakeholders (company staff, distribution partners, end users, etc.) are suitably trained and aware of the requirements of the Vigilance system appropriate to their role.

*       Assist in developing and updating SOPs, work instructions, and training materials related to vigilance activities.

*       Participate in internal and external audits and other inspections.

*       Act as a key liaison between regional teams, distributors, and global headquarters.

*       Assist the Vigilance Manager to ensure we remain up to date with applicable regulatory and legislative requirements and developments relating to Vigilance.

What Experience & Skills You Will Need:

Essential:

*       Bachelor’s degree in Life Sciences, clinical or engineering subject or a related field.

*       Postgraduate qualification in Pharmacovigilance / Medical Device Vigilance / Regulatory Affairs is an advantage.

*       3–6 years of experience in vigilance, pharmacovigilance, or medical device post-market surveillance.

Desirable:

*       knowledge of the requirements of a medical device vigilance system.

*       Prior experience with ophthalmic products is highly preferred.

*       Experience in handling global markets and multiple regulatory authorities is a strong advantage

Strong communication skills and ability to work with cross-functional global teams

What We Can Offer You:

• Comprehensive benefits package including Health and wellness allowance
• Employee Assistance Program
• Global appreciation platform to recognize colleagues around the globe
• Being part of an organization, you can be proud to work for changing the lives of millions of people!