Safety Reporting Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and coordinate the creation of regulatory and safety reports.

• Receive, prepare, and submit safety reports to relevant parties.

• Raise issues to the lead and/or line manager as needed.

• Ensure that reports adhere to regulatory deadlines and national legislation.

• Generate metrics and notify managers regarding quality or timeline concerns.

• Engage in project teams and lead projects of small to moderate scope.

• Offer training and support to team members.

• Maintain safety reporting systems and associated information.

• Collaborate with departments on safety reporting tasks and client account setups.

• Take part in audits and carry out testing activities.

• Contribute ideas and suggestions while participating in process improvement initiatives.

• Ensure the accurate and timely documentation of adverse events, supporting global pharmacovigilance compliance.

⛳️ Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification.

• Prior experience of at least 2 years in a similar role.

• Strong understanding of medical terminology.

• Excellent written and verbal communication skills.

• Proficient in Microsoft Word and Excel.

• Solid comprehension of safety database functionality.

• Strong familiarity with procedural documents.

• Knowledge of global safety reporting requirements, including FDA regulations and guidelines.

• Ability to juggle multiple tasks while delivering high-quality results.

• Exceptional attention to detail and accuracy.

• Capability to manage sensitive information and data effectively.

• Ability to interact effectively with all levels within the organization.

• Strong critical thinking and problem-solving abilities.

• Regular and reliable attendance is expected.

• Capacity to work in an upright and/or stationary position for 6–8 hours daily.

• Ability to perform frequent mobility, bending, twisting, crouching, stooping, and light to moderate lifting of up to 15–20 lbs.

• Proficiency in accessing and utilizing computer software.

• Ability to communicate and comprehend spoken and written information.

• Capability to perform under pressure and multitask effectively.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Workplace focused on scientific excellence.