Manager

Overall Experience:

10+ years of experience in drafting post-market surveillance reports for Medical Devices

Qualification:

Graduate in biomedical engineering or graduate in pharmacy or post-graduate in life sciences

Essential hiring skills:

Ability to assess technical and clinical/medical data and propose solutions

Trainable Skills:

Associate will be trained on client tools, platform, products, SOPs and templates

Delivery Location:

Pune

Responsibilities:

1) Ability to lead, coach draft, update and review PMS Plan, PMS Report/PSUR, PRER, and the Canada Summary Report for medical devices

2) Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.

3) Interpret, compile and submit right set of clinical and post market documents to respective regulatory authorities for international regulatory submissions.

4) Collaborates with cross functional teams such as PMS, Medical affairs, Literature search, Regulatory, Risk management, R&D, Sales & Marketing, etc.

5) Supporting in responding inquiries/clarification request received from regulatory authorities