AGS

J o b D e s c r i p t i o n

JOB INFORMATION
Approved Date:

Date Last Edited:

Job Profile:

Job Title: Medical Safety Writer AGS

Pay Rate Type: Salary
Reports To:

ORGANIZATION
Region: APAC
Country: India
Legal Entity:

Location:

Job Level: 6
Exemption Status: Exempt

JOB PURPOSE
• Support Global Medical Safety in preparation of regulatory safety documentation
• Ensure the safety documents comply with applicable standards and regulations across regions

JOB FUNCTIONS
Essential Functions
Duties are listed in order of greatest importance. Other responsibilities may be assigned.

1. 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
2. Gather, organize, and interpret the relevant safety data for assigned projects; interface with other functional subject
matter experts to ensure document accuracy, comprehensiveness, quality, and regulatory compliance
3. Address reviewers’ comments and manage revisions with minimal supervision
4. Support literature searches for special topics and contribute to safety summaries to address health authority queries or
signal management activities, as needed
5. Support the preparation of safety document templates, continuous improvement initiatives, or other department projects
for clinical safety or post-market surveillance

QUALIFICATIONS
Minimum Education
• Bachelor’s degree in health sciences
Preferred Education
• Advanced degree in related field
• Useful disciplines: ophthalmology or optometry

Minimum Work Experience

• ≥ 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

Knowledge, Skills and Abilities

• Knowledge of safety guidelines and regulations for medical devices and/or pharmaceutical development and post-market
surveillance
• Familiarity with medical terminology and working with large databases
• Proven ability to analyze, interpret, and discuss safety information relating to multiple therapeutic areas
• Strong interpersonal, effective communication (written and verbal), and presentation skills
• Strong organization and time management skills
• Demonstrates attention to detail and accuracy
• Self-motivated, ability to work under pressure, demonstrating initiative and flexibility
• High learning agility, ability to work independently and meet targeted timelines in a team-centric environment
• Experience with (safety or others) issue management

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

Licenses and Certifications

Required/
Licenses/Certifications Licenses/Certification Details Time Frame Preferred

Language Skills
• Fluent English; excellent verbal and written communication skills
• Understanding of another language desirable