Sr Safety Specialist (Night Shift)

Position Overview

• Location Type: Office
• Job Type: Full time
• Work Schedule: Third Shift (Nights) (IST 5:30 PM to 2:30 AM)
• Salary: Not Specified

Performs and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, driven by strict timelines. Pharmacovigilance activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information. Effectively collaborates with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

Essential Functions

• Works independently to perform day-to-day PV activities.
• May participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
• Operates in a lead capacity.
• Provides assistance in the development of program and departmental procedural documents.
• May prepare for and attend audits.
• Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic areas and disease states.
• Reviews cases entered for quality, consistency, and accuracy, including review of peer reports.
• Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.

Requirements

• Education: Life Science or Clinical Science Graduate or Post Graduate
• Experience:
  • 5+ years of experience in Case Processing related activities using Argus database.
  • Hands-on working experience in PMS & CT Cases.
• Availability: Available to join immediately.
• Shift Willingness: Must be willing to work in Night Shifts (IST 5:30 PM to 2:30 AM).

Knowledge, Skills, and Abilities

• Thorough understanding of pathophysiology and the disease process.
• Strong knowledge of relevant therapeutic areas as required for processing AEs.
• Excellent critical thinking and problem-solving skills with the ability to evaluate and escalate appropriately.
• Proficient in complex clinical study administration, including budget activities and forecasting.
• Excellent oral and written communication skills, including paraphrasing skills.
• Good command of English and ability to translate information into local language where required.
• Computer literate with the ability to work within multiple databases.
• Proficient in Microsoft Office products (including Outlook, Word, and Excel).
• Thorough understanding of global regulatory requirements and 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.

Application Instructions

• Not Specified