About the job
Summary Of Position
Alcon is looking to hire a Patient Safety Specialist to join our Medical Safety team at Bangalore in India The role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products, and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives.
- Process case files according to Standard Operating Procedures (SOP).
- Work with affiliate offices to ensure required dataset has been received/requested.
- Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.
- Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).
- Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
- Launch required quality investigation records.
- Schedule expedited and periodic regulatory reports based on local and international reporting regulations.
- Perform and receive quality feedback on case management and coding.
- Adherence to all corporate compliance guidelines & corporate programs.
- Provide support in reconciliation activities and audit as required.
- Evaluate and escalate potential safety issues to management.
Key Requirements/Minimum Qualifications
- Bachelor’s degree in Science
- Desirable: Graduation in Optometry/ M Pharm/ Pharm D / BDS
- Healthcare professional with 1-3 years of experience
- Desirable: 1-3 years of experience in Medical/Product safety/Pharmacovigilance/Device Vigilance
- Review and close files within prescribed timelines
- Creates high quality regulatory reports for submission on or before assigned due dates
Shift Timings : This role may require to work in shifts.
- Knowledge and understanding of national and international medical device regulations and regulatory guidelines
- Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice Exposure to Agile and Traditional SDLC methodologies .
Employment scams: Alcon is aware of employment scams which make false use of our company name or leader’s names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website, where you can search for open positions and apply directly.
If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information, and check our website for current job openings.
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.
How to Apply?
Apply through below link