$5,00,000 Per Year
$18,00,000 Per Year
Position: Senior Clinical Data Manager We are seeking a highly qualified and motivated Senior Clinical Data Manager to join our dynamic and growing team. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Key Responsibilities: Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Qualifications and Requirements: Excellent verbal and written communication skills; fluency in English is essential. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Strong analytical and problem-solving skills with the ability to navigate complex challenges. High degree of professionalism, integrity, and alignment with organisational values. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. 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.