Local Safety Officer

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

📋 Description

• Execute the receipt, processing, and data entry of local safety cases.

• Monitor quality control (QC) and follow up on individual case safety reports (ICSRs).

• Oversee both generic and client-specific email accounts.

• Register, triage, assign, and coordinate the processing of vigilance cases.

• Dispatch follow-up requests to local reporters.

• Address queries from clients and reporters.

• Conduct regular reconciliations to ensure proper handling of vigilance reports for PLG clients.

• Assist and contribute to local pharmacovigilance initiatives executed by the Local Safety/PV department.

• Engage in audits and inspections while supporting the resulting action plans.

⛳️ Requirements

• A Bachelor’s degree in science, Industrial Biology, or Chemical Engineering.

• At least 2 years of experience in pharmacovigilance with service providers focusing on data entry and QC of cases.

• Proven ability to work under deadlines.

• Experience in client communications.

• Familiarity with EU PV regulations.

• A pharmaceutical background with a solid understanding of GVP, GCP, FDA, and regulatory standards related to drug safety.

• Comprehensive knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

• Database experience is preferred.

• Process-oriented with a passion for working with documentation.

• Proficient computer skills.

• Strong teamwork capabilities.

• Knowledge of medical terminology.

• Highly organized and adaptable.

• Excellent communication skills in English.

🏝️ Benefits

• Opportunities for career advancement.

• Chance to make a significant impact on global healthcare.

• Collaborate with an innovative, forward-thinking global team.

• Engage in purpose-driven work.

• Opportunity to shape the future of life sciences.