$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. Key Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure all cases are coded and processed per MedDRA and applicable global standards. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Qualifications and Requirements: Strong analytical and problem-solving skills with the ability to navigate complex challenges. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. 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.