About the Role
  • Ensures effective functioning of assigned projects in compliance with client agreements and applicable regulations and guidelines.
  • Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
  • Management of quality, compliance, and documentation across assigned projects.
  • Manage and monitor the workload of the department / function and alert the functional head / designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
  • Line management for assigned personnel.
  • Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations and guidances.
  • Train and mentor personnel, as needed.
  • Identify new training and development requirements relevant to the function.
  • Respond to / represent department / function during audits and inspections.
  • Author and review SOPs and other documents relevant for department/ function.
  • Handling medical enquiries received from patients, consumers, health care professionals, and others via calls, emails, fax, and mails. May be required to work as per different time zones (Non-IST, e.g. EST, GMT, etc.).
  • Development of frequently asked questions (FAQs), Standard Response Documents (SRDs).
  • Tracking and maintenance of medical enquiries.
  • Quality check of the medical enquiries responses.
  • Medical Information project setup, database setup, validation and training.
  • Other responsibilities as assigned by the Management.

Qualifications
Required:
  • 4–12 years of relevant experience working in medical information function.
  • Strong communication and time-management skills.
  • Awareness of global regulatory, pharmacovigilance, medical affairs, and medical information environment.
  • Experience in line management.