Manager, Medical Reviewer

6 days ago

Ahmedabad, Gujarat, India Amneal Pharmaceuticals Full time

Job Responsibilities:

  • Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.

  • Oversee daily operations, ensuring timely and accurate processing of adverse event reports.

  • Conduct regular performance evaluations and provide feedback to team members.

  • Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.

  • Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.

  • Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.

  • Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.

  • Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.

  • Lead internal and external audits, preparing teams for inspections and ensuring readiness.

  • Identify opportunities for process optimization and implement best practices in case processing.

  • Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.

  • Stay current with industry trends and regulatory changes, adjusting processes accordingly.

  • Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.

  • Foster a culture of continuous learning and professional development within the team.

  • Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).

  • Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.

  • Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.

  • Ad Hoc Activities: Provides comprehensive support for pharmacovigilance-related projects and activities, as delegated by the Department Head/ Designee, to ensure operational efficiency and compliance.

Required Skills:

  • Pharmacovigilance Regulations (ICH, FDA, EMA) – Advanced
  • Individual Case Safety Report (ICSR) Processing – Advanced
  • Medical Assessment & Benefit–Risk Thinking – Intermediate
  • Coding Standards (MedDRA, WHO Drug) – Advanced
  • Safety Database Management (Argus, ArisG, Veeva Vault Safety) – Advanced
  • Global Reporting Requirements – Advanced
  • Data Integrity & ALCOA+ Principles – Advanced
  • SOPs/WIs/Templates Authoring – Advanced
  • Quality Management & CAPA (Root Cause Analysis, FMEA) – Advanced
  • Audit & Inspection Readiness – Expert
  • Deviation Management & QMS – Advanced
  • Compliance Monitoring & Controls – Advanced
  • Risk Management (ICH Q9 principles) – Advanced
  • Operational Excellence - Advanced
  • Leadership and People Management - Advanced

M.B.B.S (Bachelor of medicine and Bachelor of Surgery) or Doctor of Pharmacy

Minimum of 8 years of experience in pharmacovigilance, with at least 5 years in a managerial role.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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