Job Description

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 cro...

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