Medical Safety Writer

6 days ago

Bengaluru, India Alcon Full time

Summary of Position:

- Alcon is looking to hire Medical Safety Writer to join our Medical Safety Writing team at Bengaluru in India. This role will Support Global Medical Safety in preparation of regulatory safety documentation and ensure the safety documents comply with applicable standards and regulations across region_

Key Responsibilities:

- Act as the primary author for regulatory safety information required in technical files, including but not limited to post-market surveillance plans, safety narratives, and aggregate reports (e.g., periodic safety update reports) across regions
- Address reviewers’ comments and manage revisions with mínimal supervision
- Support literature searches for special topics and contribute to safety summaries to address health authority queries or signal management activities, as needed
- Support the preparation of safety document templates, continuous improvement initiatives, or other department projects for clinical safety or post-market surveillance

Key Requirements/Minimum Qualifications:

- Bachelor’s degree in Health Sciences
- 5+ years in medical or safety writing, such as aggregate reports, safety narratives, and literature summaries
- Proficient in Microsoft Office and electronic document management systems
- Shift Timings: 12 PM to 9PM with slight flexibility

Preferred Qualifications/Skills/Experience:

- Knowledge of ophthalmic clinical practice and therapeutic area products
- 2+ years in medical device and/or pharmaceutical industry (R&D, QA, or Regulatory Affairs)

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.

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