Manager, Pharmacovigilance Operations

3 days ago

Ahmedabad City Gujarat India Amneal Full time
Description

Job Responsibilities:  

  1. Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.
  2. Oversee daily operations, ensuring timely and accurate processing of adverse event reports.
  3. Conduct regular performance evaluations and provide feedback to team members.
  4. Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.
  5. Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.
  6. Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.
  7. Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.
  8. Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.
  9. Lead internal and external audits, preparing teams for inspections and ensuring readiness.
  10. Identify opportunities for process optimization and implement best practices in case processing.
  11. Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.
  12. Stay current with industry trends and regulatory changes, adjusting processes accordingly.
  13. Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.
  14. Foster a culture of continuous learning and professional development within the team.
  15. Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).
  16. Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.
  17. Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.
  18. 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
Qualifications

Doctor of Pharmacy

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

  • Pharmacovigilance Intern

    3 days ago

    India ProPharma Group Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Pharmacovigilance Associate

    2 weeks ago

    Ahmedabad, Mumbai, Pune, India Airvin Skills Full time ₹ 3,00,000 - ₹ 6,00,000 per year

    We are seeking a highly motivated and detail-oriented recent graduate to join our Pharmacovigilance team as an Entry-Level Pharmacovigilance Associate. This is a fantastic opportunity to begin your career in the pharmaceutical industry and contribute to the safety monitoring of our products. You will gain hands-on experience in various aspects of...

  • Pharmacovigilance Safety Scientist

    2 days ago

    India ProPharma Group Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Executive Pharmacovigilance

    7 days ago

    Vadodara, Gujarat, India Novumgen Full time

    **Pharmacovigilance - Executive** **Job Details**: - **Adverse Drug Reaction (ADR) Reporting** - Collecting and analyzing reports of side effects from healthcare professionals and patients. - **Data Management** - Organizing and assessing drug safety data from clinical trials and post-market surveillance. - **Regulatory Compliance** - Ensuring adherence to...

  • Pharmacovigilance Systems Specialist

    4 weeks ago

    Chennai, India ICON plc Full time

    Job Description Pharmacovigilance Systems Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Pharmacovigilance...

  • Pharmacovigilance Manager

    3 weeks ago

    Hyderabad, India ProPharma Full time

    Job Description For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate...

  • Pharmacovigilance System Analyst

    2 weeks ago

    india beBeeBusiness Full time

    Job OverviewWe seek a highly experienced IT professional with deep expertise in Pharmacovigilance systems, specifically Signal Management and Risk Management modules.Main Responsibilities:Serve as the senior Subject Matter Expert for Signal Management and Risk Management platforms, owning system functionality, enhancements, and solutioning.Lead requirement...

  • Pharmacovigilance Drug Safety Physician SAL

    1 day ago

    India ProPharma Group Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Pharmacovigilance Drug Safety Physician SAL

    4 weeks ago

    Hyderabad, India ProPharma Full time

    Job Description For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate...

  • Tech-Functional Business Analyst – Signal

    4 weeks ago

    India vueverse. Full time

    Role SummaryWe are looking for a highly experienced IT/Tech-Functional Business Analyst (12+ years) with deep expertise in Pharmacovigilance (PV) systems, specifically Signal Management and Risk Management modules. The role requires strong techno-functional capability to bridge business requirements with system design, configuration, integrations, and...