ADVANZ PHARMA is hiring for two Patient Safety positions in Andheri, Mumbai, with a hybrid working model. The openings are Senior Executive, Patient Safety and Manager, Patient Safety, focused on Pharmacovigilance compliance, Safety Data Exchange Agreements (SDEAs), Pharmacovigilance System Master Files (PSMFs), PV training, audits, inspections, and regulatory compliance.
Job Details
| Details | Information |
|---|---|
| Company | ADVANZ PHARMA |
| Positions | Senior Executive, Patient Safety; Manager, Patient Safety |
| Location | Andheri, Mumbai, India |
| Work Model | Hybrid |
| Date | October 8, 2026 |
| Qualification | University degree in a Life Science + Postgraduate qualification |
| Function | Patient Safety / Pharmacovigilance |
Positions
1. Senior Executive, Patient Safety
The Senior Executive, Patient Safety will support global Pharmacovigilance activities related to SDEAs and PSMFs, ensuring regulatory compliance, inspection readiness, and effective collaboration with internal stakeholders and external business partners.
2. Manager, Patient Safety
The Manager, Patient Safety will manage PSMFs, SDEAs, and Pharmacovigilance training programs across ADVANZ PHARMA’s global PV operations, while supporting compliance, audits, inspections, and continuous improvement of the Pharmacovigilance system.
Responsibilities
Senior Executive, Patient Safety
- Write, track, and maintain Safety Data Exchange Agreements (SDEAs).
- Support reconciliation and maintenance of PSMFs.
- Coordinate with partners and internal stakeholders to review and finalize agreements.
- Maintain the SDEA tracking system and responsibility matrix.
- Act as a primary PV contact for SDEA-related matters.
- Support writing and maintenance of global and regional PSMFs.
- Maintain PSMF annexes and supporting documentation.
- Coordinate contributions from relevant stakeholders.
- Support PV audits and inspections, including preparation and CAPA management.
- Manage local literature surveillance and regulatory intelligence activities.
- Collaborate across business functions to support Pharmacovigilance compliance and operational activities.
Manager, Patient Safety
- Act as a subject matter expert for writing and managing SDEAs and PSMFs.
- Lead negotiation, review, execution, maintenance, and reconciliation of SDEAs with ADVANZ PHARMA partners.
- Ensure SDEAs and associated obligations are aligned with applicable guidelines.
- Serve as the primary PV contact for internal stakeholders and external business partners.
- Oversee preparation, maintenance, review, quality control, approval, and periodic updates of global and regional PSMFs.
- Establish and maintain inspection-ready processes and documentation.
- Support audits and inspections from PSMF and SDEA perspectives.
- Lead development, maintenance, implementation, and continuous improvement of PV training programs.
- Ensure delivery and documentation of PV and GVP training.
- Monitor training compliance and effectiveness and implement corrective and preventive actions where required.
- Participate in the preparation, review, and maintenance of SOPs, Work Instructions, templates, and PV documentation.
- Monitor evolving global Pharmacovigilance regulations and industry best practices.
- Ensure relevant regulatory requirements are implemented within the area of responsibility.
Eligibility & Qualifications
For both positions, candidates should have:
- A University degree in a Life Science.
- A Postgraduate qualification.
Senior Executive – Experience & Knowledge
- Extensive experience in Pharmacovigilance compliance, including SDEAs, PSMFs, and PV training programs.
- Experience supporting Pharmacovigilance audits and inspections.
- Experience managing cross-functional and external stakeholder relationships.
- Strong understanding of Pharmacovigilance regulations, including EU GVP, UK, and regional requirements.
- Strong oral and written communication skills.
- Ability to work collaboratively and take accountability for results.
Manager – Experience & Knowledge
- Extensive experience in Pharmacovigilance compliance, including management of SDEAs, PSMFs, and PV training programs.
- Experience supporting Pharmacovigilance audits and inspections.
- Experience managing cross-functional and external stakeholder relationships.
- Experience leading compliance and process improvement initiatives within Pharmacovigilance.
- Strong understanding of EU GVP, UK, and regional Pharmacovigilance requirements.
- Strategic mindset with a results-driven and stakeholder-centric approach.
- Strong oral and written communication skills.
- Ability to work collaboratively and take accountability for results.
Required Skills
- Pharmacovigilance
- Patient Safety
- Safety Data Exchange Agreements (SDEAs)
- Pharmacovigilance System Master Files (PSMFs)
- PV Compliance
- EU GVP
- Pharmacovigilance Audits & Inspections
- Regulatory Intelligence
- Literature Surveillance
- PV Training
- SOPs and Work Instructions
- CAPA
- Stakeholder Management
- Cross-functional Collaboration
- Regulatory Compliance
Benefits & Working Environment
ADVANZ PHARMA lists the following global benefits:
- Global recognition programme
- Long Service Award
- Employee Assistance programme
- Birthday leave
- Wellbeing day
- Volunteering leave
- Compassionate leave
- Agile working for office-based employees
- Work from Anywhere subject to local legislation for non-field-based employees
The company also describes a working environment focused on trust, collaboration, inclusion, continuous development, entrepreneurship, speed, and integrity.
Application Details
Company: ADVANZ PHARMA
Positions: Senior Executive, Patient Safety & Manager, Patient Safety
Location: Andheri, Mumbai, India
Work Model: Hybrid
Date: October 8, 2026
Qualification: University degree in Life Science + Postgraduate qualification