Senior Executive Patient Safety

ADVANZ PHARMA Corp.; Mumbai; Hybrid; INR 800,000 - 1,200,000; Full time

Job summary

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

The role involves drafting and maintaining SDEAs, contributing to PSMFs, and coordinating PV activities with internal and external stakeholders in a hybrid work setting.

Qualifications

• Degree in Life Sciences with a postgraduate qualification.
• Experience in Pharmacovigilance, SDEAs, and PSMFs.
• Strong understanding of global PV regulations.

Responsibilities

• 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.

Skills

PV experience

SDEAs

PSMFs

Stakeholder mgmt

Global PV regulations

Education

Bachelor's degree in Life Sciences

Postgraduate qualification

Job description

Job Description:

We're Hiring | Senior Executive, Patient Safety

Andheri, Mumbai | Hybrid Working

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

Key Responsibilities

• 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.

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