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Vantive
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Sr Executive, Product Surveillance

Sr Executive, Product Surveillance

Vantive

2 - 5 years

4 - 7 Lacs

gurugram

Posted:None| Platform:

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Skills Required

training due diligence technical services compliance senior executive finance plant quality database management recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Gather complaint information from reporter (examples: performing due diligence, facilitating sample retrieval, etc);
Ensure consistency of complaint records & proper documentation (Good Documentation Practices); Assess complaint information to determine regulatory reportability as per procedures & regulations; Work with plant quality organizations, technical services and/or suppliers to coordinate complaint investigations; Maintain compliance to regulations and procedures; Work on Post Market Surveillance requirements as part of the EU Medical Device Regulations, including but not limited to: - Post Market Surveillance Plans; - Post Market Surveillance Reports; - Periodic Safety Update Reports (PSURs); - Clinical Evaluation Reports (CERs) Ensure any emerging trends from the field or other PMS data are highlighted and reported to relevant management in real time.

Ensure accurate and detailed documentation of complaint information.
Stay informed about applicable regulations and guidelines related to vigilance reporting. Initiate and complete vigilance reports within regulatory timelines. Maintain a comprehensive database of vigilance reports for internal tracking. Provide training to team members on new processes and updates.

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Sr Executive, Product Surveillance