Job Description

Required Skills/Experience:

  • Knowledge of pharmacovigilance and regulatory requirements of key regulatory authorities.
  • Ability to work independently with minimal supervision.
  • Strong communication and time management skills.
  • Proven experience in team handling, including mentoring, performance management, and task delegation.

Key Responsibilities:

  • Ensure the effective functioning of pharmacovigilance (PV) projects in compliance with client agreements and applicable regulations/guidelines.
  • Take ownership of assigned projects and tasks, ensuring adherence to timelines and quality standards.
  • Manage quality, compliance, and documentation across PV projects.
  • Alert the functional head/designate regarding any personnel management concerns that may impact work quality or functioning.
  • Collaborate continuously with internal and external stakeholders to ensure compliance with agreements, regulations, and guidance.
  • Train and mentor personnel as needed.
  • Identify and address training and development needs relevant to the function.
  • Represent the department/function during audits and inspections.
  • Author and review SOPs and other relevant documents as assigned by Management.
  • Monitor and manage departmental workload, escalating concerns to the functional head/designate when necessary.
  • Provide line management for assigned personnel as designated by Management.
  • Perform other responsibilities as assigned by Management.