Senior Drug Safety

Key Responsibilities

Case Management and Reporting

• Support the Pharmacovigilance team in collecting, tracking, and processing Adverse Events (AEs) from all sources with accuracy and efficiency.
• Independently triage AEs to determine reportability in compliance with regulatory guidelines and clinical assessment standards.
• Code AEs using MedDRA and WHODRUG, applying clinical judgment to ensure correct categorization.
• Conduct quality control checks on case data to ensure accuracy, consistency, and completeness in safety databases and regulatory reporting forms (e.g., MedWatch, CIOMS I).

Regulatory Compliance and Documentation

• Ensure timely submission of expedited case reports to regulatory authorities in compliance with global regulations.
• Draft concise and clinically sound AE narratives following established guidelines.
• Formulate and communicate follow-up queries to clients or stakeholders for additional case information.
• Assist in the preparation of aggregate reports and regulatory documentation as required.

Collaboration and Leadership

• Work collaboratively with PV management, project managers, and internal teams to meet deadlines and project goals.
• Lead and mentor junior staff, including Drug Safety Associates and Drug Safety Coordinators, in case processing.
• Participate in the regular reconciliation of Serious Adverse Events (SAEs) between drug safety and clinical trial databases.

Continuous Improvement and Development

• Gain deep knowledge of client products and therapeutic areas.
• Contribute to the creation and maintenance of SOPs, work instructions, and other pharmacovigilance documentation.
• Stay current with evolving drug safety regulations and contribute to ongoing process improvements within the team.

Qualifications

Education

• Bachelor's degree in a life sciences discipline (e.g., Pharmacy, Nursing) is preferred.

Experience

• Minimum of 5 years of experience in pharmacovigilance, including at least 3 years in drug safety.
• Broad knowledge of domestic and international regulations, including ICH and FDA guidelines.
• Strong understanding of the drug development process and AE reporting requirements.

Skills

• Proficient in MedDRA and WHODRUG coding.
• Familiar with FDA and international AE reporting regulations.
• High attention to detail and ability to manage complex data accurately.
• Excellent written and verbal communication skills, especially in crafting clear narratives.
• Strong time management and multitasking abilities.
• Proficiency in Microsoft Office and safety database software.