Job Title: Senior Manager – Patient Safety
Location: Andheri (East), Mumbai, India (Hybrid)
Company: Advanz Pharma
Job Type: Full-Time
Company Overview:
Advanz Pharma is a global pharmaceutical company dedicated to improving patients’ lives by delivering specialty, hospital, and rare disease medicines. Headquartered in London, UK, and operating across more than 20 countries, Advanz Pharma collaborates with innovative biopharma and pharmaceutical partners to bring essential medicines to patients worldwide. The Mumbai Centre of Excellence complements global operations and supports the commercialization of specialty medicines across Europe, Canada, and Australia.
Role Overview:
Advanz Pharma is seeking a Senior Manager, Patient Safety to lead global and regional pharmacovigilance activities. This role will oversee the creation, maintenance, and review of Reference Safety Documents such as CCDS, SmPC, PI, PIL, datasheets, and product monographs for all Advanz Pharma products, ensuring compliance with applicable global and regional regulations. The ideal candidate will have extensive experience in safety management for innovator drugs, branded generics, generics, and biosimilars.
Key Responsibilities:
Draft and review Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs) from a medical perspective.
Prepare and manage signal detection reports (DSR, DEP, SAR) ensuring compliance and quality.
Provide medical writing support for product safety reviews, clinical evaluations, and regulatory submissions.
Draft or review ad hoc safety reports including Risk Management Plans (RMPs), Clinical Evaluation Summaries (CES), and responses to health authorities.
Maintain oversight of safety-related variations and product information updates.
Keep abreast of evolving pharmacovigilance requirements across Europe, India, and the rest of the world.
Represent the company in scientific meetings, audits, and inspections.
Ensure compliance with Good Pharmacovigilance Practices (GVP) and industry standards.
Manage interactions with regulators, patients, and healthcare professionals from a safety perspective as required.
Contribute to continuous improvement of safety systems, processes, and documentation quality.
Qualifications & Experience:
Education: MD/MBBS.
Proven experience in signal detection, aggregate reporting, and safety management.
Previous team management experience is preferred.
Strong understanding of global pharmacovigilance regulations, patient safety standards, and post-marketing surveillance.
Why Join Advanz Pharma:
Be part of a global pharmaceutical leader with a mission to improve patient outcomes.
Work in an inclusive, agile, and fast-paced environment where innovation and entrepreneurship are encouraged.
Access professional growth opportunities, flexible work options, and a competitive salary and benefits package.
Thrive in a culture that values diversity, gender equality, and internal promotion opportunities.
Collaborate with cross-functional teams and contribute to global pharmacovigilance strategies for specialty and rare disease medicines.
Application Process:
Interested candidates are invited to apply online by submitting a current CV and cover letter. Advanz Pharma is committed to equal employment opportunities and fostering an inclusive workplace.
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