Senior Pharmacovigilance Analyst

Kelly Science, Engineering, Technology & Telecom; India; Sur place; INR 1 200 000 - 2 000 000; Plein temps

Résumé du poste

A global leader in consumer health is seeking a Senior Pharmacovigilance Analyst in India. The role involves managing commercial agreements, ensuring compliance with guidelines, and improving PV processes. Candidates should have 3+ years of experience in the pharmaceutical industry, strong knowledge of pharmacovigilance, and fluent English. This full-time position is based in Vishakhapatnam, Andhra Pradesh.

Qualifications

• 3+ years of pharmaceutical industry experience, including product vigilance responsibilities.
• Experience in pharmacovigilance agreement review and related PV activities.
• Ability to connect in a global organization.

Responsabilités

• Manage oversight of commercial agreements across all regions.
• Ensure commercial agreements are reviewed for Pharmacovigilance Agreement recommendations.
• Collaborate with PVA Hub Lead to implement CAPA plans.
• Ensure accuracy of PSMF Annex B Commercial Agreements listing.
• Contribute to PVA process improvement initiatives.
• Perform periodic Local PVA Reconciliations (ICSR) with Business Partners.
• Support the LSOs on applicable operational tasks related to PVA.
• Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
• Collaborate with the PVA Hub Lead to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

Connaissances

Pharmacovigilance Agreement review

Product vigilance responsibility

Fluent English

Medical terminology knowledge

General medicine knowledge

Description du poste

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On behalf of our client, a global leader in consumer health, we are seeking Senior Pharmacovigilance Analyst. In this role you will support the Local Pharmacovigilance Organization in several PV processes and compliance tasks related to the vigilance of product portfolio.

Responsibilities

• Manage and maintain oversight of commercial agreements across all regions.
• Ensure commercial agreements are reviewed to assess if a Pharmacovigilance Agreement (PVA) is recommended.
• Review the draft PVA to ensure its accuracy and support negotiation with Business Partners and execution in partnership with LSOs.
• Ensure accuracy of PSMF Annex B Commercial Agreements listing.
• Contribute to PVA process improvement initiatives.
• Perform periodic Local PVA Reconciliations (ICSR) with Business Partners.
• Support the LSOs on applicable operational tasks related to PVA.
• Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
• Collaborate with the PVA Hub Lead to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

Required Qualifications

• 3+ years of pharmaceutical industry experience including product vigilance responsibility role.
• Experience in Pharmacovigilance Agreement review and related PV activities.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
• Fluent communication skills in English, any additional language is a plus.
• Ability to connect in a global organization.

Desired Qualifications

• Sound knowledge of medical terminology.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting

Industries

• Pharmaceutical Manufacturing

Vishakhapatnam, Andhra Pradesh, India 19 hours ago