Chethana M
Mysuru
Summary
Professional with nine years of experience in medical information contact center operations and clinical data management. Proven track record in adverse event reporting and product complaint handling for major pharmaceutical companies across multiple regions, resulting in enhanced operational efficiency. Skilled in team training, compliance assurance, and client relationship management. Results-driven Process Lead focused on optimizing workflows and ensuring timely project completion.
Overview
10
10
years of professional experience
Work History
Associate process lead
OrciMed Life Sciences, Hyderabad
Hyderabad
02.2025 - Current
- Oversees the daily operations of a team that handles medical information inquiries, adverse event reports, and product complaint handling, ensuring compliance with company and client standards.
- Supervising and mentoring team members regarding product-specific updates, SDEA with partners.
- Oversees operations related to trackers, and documents are regularly updated, and reconciliations are completed on time.
- Providing initial and ongoing training.
- Ensuring staff proficiency in handling medical information inquiries, adverse event reports, and product complaints.
- Monitoring team performance and providing feedback.
- Managing team schedules and delegating tasks.
- Resolving conflicts and addressing performance issues.
- Facilitating communication between team members, clients, and other departments.
- Participating in meetings and providing updates to clients on day-to-day case volume, preparation of weekly, monthly, and quarterly reports.
- Escalating issues and risks to the appropriate management team.
- Led process improvement initiatives to enhance operational efficiency.
SME and Trainer (Drug safety Scientist)
Qinecsa India Pvt Ltd, Mysuru
Mysuru
09.2017 - 02.2025
- Training new associates and getting them certified by the client by facilitating and providing process-related training.
- Handling escalated cases of medical inquiries, adverse event reports, and product complaints of drugs and devices to resolve the issue.
- Performing reconciliation and invoice preparation.
- Quality check of case narratives written by associates in IRMS and also litening call recordings to assure completeness and accuracy of the data entered in the application.
- Provided expert guidance on industry best practices and compliance standards.
- Conducted training sessions to enhance team knowledge and skills in subject areas.
- Mentored junior staff, providing support in problem-solving and professional development.
- Working with pharmaceutical companies (clients) about reported safety information.Identifying trends in MI, AE PC cases, and products so that necessary action can be taken by the client to identify the issue.
- Review and evaluate AE case information to determine the required action based on internal policies and procedures. Following patient safety regulatory obligations and regulatory pharmacovigilance guidelines.
- Handling medical information calls and emails for the USA, Canada, Australia, and India. Identify adverse events reported by consumers and product complaints reported. Required information will be collected in the call.
- Performing follow-up calls to patients or HCPs to share information regarding their queries or investigation outcomes for product complaints and also to collect additional information.
- Facilitating prepaid mailers to patients and pharmacies to retrieve compliant products from the USA and European region to the manufacturing site for investigation purposes.
Senior Process associate (Clinical data management)
Accenture, Bengaluru
Bengaluru
08.2015 - 09.2016
- Review of clinical data for study protocol.
- Timely resolution of discrepancies related to study.
- Determination of any incomplete CRF pages.
- Assisting clinical site person/client for data management through calls and emails.
Education
Master of science - Zoology
Manasagangotri University of Mysore
Mysuru06-2015
Bachelor of science - Biology And Chemistry
University of Mysore
Mysuru05-2013
Skills
- Medical information team management
- Managing medical information contact team members located in the Philippines
- Adverse event reporting
- Product complaint handling for drugs and devices
- Process improvement
- Quality assurance
- Clinical data management
- Client relationship management
- Team leadership
- Effective communication
- Training facilitation
- Clinical database RDC, IRMS, LSMI, ARISg/LifeSphere Safety, and MS application
Languages
Kannada, English and Hindi
Disclaimer
I hereby declare that the above-mentioned information is correct to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Timeline
Associate process lead
OrciMed Life Sciences, Hyderabad
02.2025 - Current
SME and Trainer (Drug safety Scientist)
Qinecsa India Pvt Ltd, Mysuru
09.2017 - 02.2025
Senior Process associate (Clinical data management)
Accenture, Bengaluru
08.2015 - 09.2016
Master of science - Zoology
Manasagangotri University of Mysore
Bachelor of science - Biology And Chemistry
University of Mysore