Associate Drug Safety Specialist (Night Shift)

Position Overview

• Location Type:
• Job Type: Full time
• Work Schedule:
• Employment Type: Full time

This role involves performing day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment with strict timelines. Activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information.

Responsibilities

• Performs adverse event data entry, coding, and assessment.
• Conducts case review, follow-up, and tracking of reports.
• Manages regulatory reporting activities.
• Collaborates effectively with project team members, client contacts, investigators, reporters, and third-party vendors.
• May participate in on-call duties for 24-hour coverage of case intake from investigative sites.
• Reviews regulatory/pharmacovigilance publications to stay updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic areas and disease states.
• Reviews cases for quality, consistency, and accuracy, including peer reports.
• Prepares and maintains regulatory safety reports.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Experience: Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• Skills and Abilities:
  • Strong critical thinking and problem-solving skills.
  • Good oral and written communication skills, including paraphrasing.
  • Good command of English and ability to translate information into local languages where required.
  • Computer literate with the ability to work within multiple databases.
  • Previous exposure to Microsoft Office packages (Outlook, Word, Excel).
  • Understanding of medical terminology.
  • Understanding of the importance of and compliance with procedural documents and regulations.
  • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.
  • Strong attention to detail.
  • Ability to maintain a positive and professional demeanor in challenging circumstances.
  • Ability to work effectively within a team to attain a shared goal.

Environmental Conditions