Overview:

The GPV Case Management Product Specialist ensures compliance with safety reporting obligations, manages ICSR workflows, and supports pharmacovigilance (PV) operations by collaborating with internal teams, vendors, and business partners.

Key Responsibilities:

• Oversee ICSR workflows, ensuring deadlines and compliance requirements are met.
• Manage and support case management vendors, including troubleshooting and escalation.
• Process and oversee AE reports from clinical trials and post-marketing sources.
• Act as an SME for MedDRA coding and ICSR handling during inspections and audits.
• Manage PV vendors and coordinate with CROs and business partners on case management issues.
• Investigate CAPA findings and implement corrective and preventive actions.
• Provide training, develop guidance documents, and support safety operations for assigned studies.
• Perform end-to-end case processing, including triage, data entry, assessments, and quality reviews.
• Participate in UAT activities for case management initiatives and assist with database queries for AE listings.
• Support PV inspections/audits and collaborate with the Clinical Research Department.

Qualifications:

• Bachelor’s degree in a scientific field (e.g., Nursing, Pharmacy).
• 4 to 7 years of pharmacovigilance experience.

Required Skills:

• Strong knowledge of global safety reporting regulations (FDA, ICH, EU).
• Proficiency in ARGUS Safety Database and case processing.
• Experience managing vendors, partners, and CROs.
• Excellent technical, communication, and project management skills.
• Proficiency with Microsoft Office Suite.
• Strong attention to detail, problem-solving, and multitasking abilities.