$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Scope of Responsibilities: Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Ability to work both independently and in a team-oriented, collaborative environment. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.