$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Scope of Responsibilities: 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. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Conduct structured literature reviews and contribute to scientific summaries and labelling. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Competencies and Qualifications: Detail-oriented mindset with the ability to synthesise and present complex information clearly. Commitment to ongoing professional learning and industry knowledge enhancement. Ability to work both independently and in a team-oriented, collaborative environment. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. 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. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.