Complaint Handling Vigilance Officer

3 weeks ago


Mysore, India KServe BPO Private Limited Full time

1. Identification of Reportable and Not Reportable events.
2. Submission of Medical device Reports( MDR) and Medical Device Vigilance Report
(MDVR)
3. Awareness about basic Medical Regulatory standards (13485,14971,21CFR(803)
etc)
4. Hands on experience must on MDR reporting and submission to Regulatory
Authorities (Any one ex: US, EU, Canada...)
5. Overall 2 to 5 yrs exp in Medical domain in (PMS, complaint handling,
Pharmacovigilance and MDR Reporting
6. As per regulation, creating the MedWatch 3500 form for the incident such as
Adverse event and malfunction submission to FDA
7. Evaluating the complaints, incident analysis, investigating, Analysis of root cause of
adverse event, malfunction of device and implementation of corrective action.
**Tools knowledge :Track wise, SAP, Web Trader, E-submitter.**

**Job Type**: Contract
Contract length: 12 months

**Salary**: ₹40,000.00 - ₹60,000.00 per month

Ability to commute/relocate:

- Mysore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- relevant work: 2 years (required)

**Speak with the employer**
+91 9820698575



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