Senior Executive - Case Processing (CT Cases)

Job Description

A leading company is seeking a Senior Executive for Case Processing, specializing in clinical trial safety (CT Cases). This role is based in India and involves managing Serious Adverse Event (SAE) reporting and ensuring compliance with safety regulations.

Responsibilities:

• Collects, records, and checks SAEs from clinical investigations and trials.
• Generates queries for additional information on AEs/SAEs.
• Reports AEs/SAEs to the Sponsor.
• Prepares case narratives, CIOMS I Forms, and SAE Forms.
• Manages the Safety Database.
• Acts as a point of contact and escalation for safety matters with the Sponsor.
• Reports Suspected Unexpected Serious Adverse Reactions (SUSAR) to regulatory bodies.
• Manages unblinding information.
• Performs periodic safety reporting.
• Ensures tracking and documentation of AE/SAE correspondence.
• Supervises and manages safety issues during the post-marketing phase.
• Prepares and reviews Safety Plans and AE/SAE Reconciliation Plans.
• Participates in system, qualification, and project audits.
• Revises the Safety section during protocol writing.
• Writes SOPs and Working Instructions.

Requirements:

• University Degree in scientific, medical, or paramedical disciplines.
• At least six (6) years of Safety experience.
• Excellent understanding of safety regulations in EU Member States (e.g., ICH, CT3, MDD, AIMDD, MEDDEVs).
• Ability to research safety requirements in International and National Regulation.
• Fluent in English.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.