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)
- Experience in the medical profession or regulatory risk management
- Excellent medical/technical writing skills
- Excellent oral communication skills
- Experience with advanced wound therapeutics product / process knowledge is preferred
Responsibility of / Expectations from the Role :
- Associate is required to work in US shift. Typical work timings will be from 6.30 pm IST – 3.30 am IST
- Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals.
- Gathers Patient Health Records that pertain to the reported event.
- May conduct phone interviews with patients, family members, and/or healthcare providers to obtain necessary information to complete the investigation of the reported event
- Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion.
- Manages and maintains adverse event files and MDR (Medical Device Report) tables within the Complaint System
- 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
- Conforms to and enforces clients policies and procedures as related to job function.
- Hospital & Health Care
- Health Care Provide