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.