Pharmacovigilance Services Assoc Manager

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance

Designation: Pharmacovigilance Services Assoc Manager

Qualifications: MBBS

Years of Experience: 10 to 14 years

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What would you do?

• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP
• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP
• Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for?
• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.
• Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database.
• Write company causality comment Roles and Responsibilities:
• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.
• Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database.
• Write company causality comment and route the case to applicable workflow as per Client SOPs
• Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs
• Lead the training of internal and cross-functional team members.
• Actively involved in case discussion with client and provide the valuable inputs to the team.
• Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates.
• Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs