Senior Executive, Patient Safety

ADVANZ PHARMA Corp.; Mumbai; Presencial; INR 1.200.000 - 2.000.000; Jornada completa

Descripción de la vacante

ADVANZ PHARMA is seeking a Senior Executive, Patient Safety to join our Medical Office team and support global Pharmacovigilance compliance. The role focuses on drafting and maintaining SDEAs, preparing PSMFs, coordinating PV activities, and ensuring inspection readiness across regions.

You will collaborate with internal stakeholders and external partners, manage literature surveillance, and contribute to robust PV systems in a fast-paced, international pharmaceutical environment.

Formación

• Degree in Life Sciences with a postgraduate qualification in Pharmacovigilance (PV)
• Experience in Pharmacovigilance, SDEAs, and PSMFs
• Strong understanding of global PV regulations
• Excellent stakeholder management and communication skills
• Proactive, collaborative, and solution-focused mindset

Responsabilidades

• Draft, review, track, and maintain Safety Data Exchange Agreements (SDEAs)
• Support the preparation and maintenance of global and regional PSMFs
• Coordinate with internal stakeholders and external partners on PV agreements and compliance activities
• Maintain SDEA trackers, responsibility matrices, and related documentation
• Support PV audits, inspections, and CAPA management activities
• Ensure compliance with EU GVP, UK, and global Pharmacovigilance requirements
• Manage local literature surveillance and regulatory intelligence activities
• Contribute to maintaining an inspection-ready and robust PV system

Conocimientos

Pharmacovigilance

SDEAs

PSMF

Stakeholder management

Communication

Educación

Life Sciences degree

Postgraduate PV qualification

Descripción del empleo

ADVANZ PHARMA is seeking a Senior Executive, Patient Safety to join our Medical Office team and support global Pharmacovigilance compliance activities.

• Draft, review, track, and maintain Safety Data Exchange Agreements (SDEAs)
• Support the preparation and maintenance of global and regional PSMFs
• Coordinate with internal stakeholders and external partners on PV agreements and compliance activities
• Maintain SDEA trackers, responsibility matrices, and related documentation
• Support PV audits, inspections, and CAPA management activities
• Ensure compliance with EU GVP, UK, and global Pharmacovigilance requirements
• Manage local literature surveillance and regulatory intelligence activities
• Contribute to maintaining an inspection-ready and robust PV system

What We're Looking For:

• Degree in Life Sciences with a postgraduate qualification
• Experience in Pharmacovigilance, SDEAs, and PSMFs
• Strong understanding of global PV regulations
• Excellent stakeholder management and communication skills
• A proactive, collaborative, and solution-focused mindset

At ADVANZ PHARMA, you'll play a key role in improving patient access to medicines while growing your career in a fast-paced, international pharmaceutical company.