Medical Compliance Specialist Company,Tata Consultancy Services Company Location New Delhi, Delhi, India

Medical Compliance Specialist Tata Consultancy Services Company Location New Delhi, Delhi, India

Role Title : Medical Compliance Specialist

Role Summary : The Medical Compliance Specialist prepares and maintains adverse event files and compiles adverse event investigation information. He/She investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required.

Required Technical Skill Set : Bachelor of Medicine degree or Bachelor of Science degree in Nursing or other related medical degree (e.g. risk management)

Desired Experience Range : A minimum of 2 years of experience with regulatory / quality compliance within a pharma or medical device industry

Location of Requirement : TCS New Delhi – Noida V SEZ

 

Desired Competencies (Technical/Behavioral Competency)

Must-Have :

• Experience in the medical profession or regulatory risk management
• Excellent medical/technical writing skills
• Excellent oral communication skills

Good-to-Have

• Experience with advanced wound therapeutics product / process knowledge is preferred

 

Responsibility of / Expectations from the Role :

1. Associate is required to work in US shift. Typical work timings will be from 6.30 pm IST – 3.30 am IST
2. Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals.
3. Gathers Patient Health Records that pertain to the reported event.
4. May conduct phone interviews with patients, family members, and/or healthcare providers to obtain necessary information to complete the investigation of the reported event
5. Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion.
6. Manages and maintains adverse event files and MDR (Medical Device Report) tables within the Complaint System
7. Creates, organizes and manages regulatory files and documentation including Food and Drug Administration (FDA) and prepares the submissions, annual reports, and ad hoc reports for Competent Authorities
8. Conforms to and enforces clients policies and procedures as related to job function.