Location: Mumbai, Maharashtra, India
Company: Roche
Department: Research & Development / Pharmacovigilance
Job ID: 202604-109903
Experience Required: Minimum 3 Years in Pharmacovigilance (Freshers Eligible)
About Roche
Roche is one of the world’s leading healthcare and biotechnology companies dedicated to advancing science, improving patient outcomes, and transforming healthcare globally. With more than 100,000 employees worldwide, Roche continues to innovate across pharmaceuticals and diagnostics to create a healthier future for millions of patients.
The company promotes an inclusive and growth-oriented work culture where professionals are empowered to contribute meaningfully to global healthcare innovation.
Job Overview – Patient Safety Partner
Roche is hiring an experienced Patient Safety Partner for its Mumbai location to strengthen its Pharmacovigilance and Drug Safety operations in India. This role is responsible for maintaining local pharmacovigilance excellence, ensuring regulatory compliance, driving patient safety initiatives, and supporting global and regional PV strategies.
The ideal candidate should possess strong expertise in pharmacovigilance systems, regulatory compliance, risk management, aggregate reporting, signal detection, and patient safety operations within the pharmaceutical industry.
This is an excellent opportunity for experienced Pharmacovigilance professionals looking to work with one of the top global pharmaceutical companies in India.
Key Responsibilities
Pharmacovigilance Operations & Safety Management
Execute core pharmacovigilance activities in collaboration with Patient Safety Operations and Affiliate PV teams
Monitor product safety profiles and implement risk management strategies
Ensure compliance with Indian and global pharmacovigilance regulations
Support inspection readiness and maintain the company’s License to Operate
Individual Case Safety Reports (ICSRs)
Manage safety data collection and case processing activities
Ensure timely and compliant handling of adverse event reports
Support medical review and safety documentation processes
Signal Detection & Aggregate Reporting
Conduct signal detection and signal management activities for local products
Support preparation and submission of aggregate safety reports to health authorities
Identify emerging safety trends and communicate risks proactively
Risk Management & Safety Communication
Support implementation of Risk Management Plans (RMPs)
Coordinate Direct Healthcare Professional Communications (DHPCs)
Collaborate with Medical Affairs and regulatory stakeholders on safety communications
Pharmacovigilance Agreements & Compliance
Manage Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements
Ensure compliance with Roche global PV procedures and Indian PV regulations
Maintain and update the Pharmacovigilance System Master File (PSMF)
Quality Management System (QMS)
Manage CAPAs, deviations, non-conformances, and root cause analysis investigations
Ensure inspection-ready documentation and data integrity across PV systems
Support audits, regulatory inspections, and PV training compliance
Cross-Functional Collaboration
Work closely with Regulatory Affairs, Clinical Operations, Medical Affairs, and Quality teams
Support safety launch readiness for priority therapeutic areas
Participate in affiliate safety communities and PV strategic initiatives
Required Qualifications
Degree in Pharmacy, Medicine, Life Sciences, or related healthcare discipline
Minimum 3 years of experience in Pharmacovigilance or Drug Safety within the pharmaceutical industry
Strong understanding of Indian PV regulations, FDA, EMA, ICH-GCP guidelines, and global safety requirements
Hands-on experience with:
Signal Detection
Aggregate Reporting
Risk Management Plans
Safety Databases
PV Compliance Activities
CAPA Management
PSMF Maintenance
Experience working with PV systems such as:
Veeva Vault Safety
ArisG
Safety databases and quality systems
Preferred Skills
Strong analytical and problem-solving abilities
Excellent communication and stakeholder management skills
Experience in audit and inspection readiness
Knowledge of post-marketing surveillance and clinical trial safety
Ability to manage multiple pharmacovigilance priorities in a global environment
Why Join Roche?
Opportunity to work with one of the world’s top pharmaceutical and biotechnology companies
Exposure to global pharmacovigilance operations and international regulatory standards
Collaborative, innovation-driven, and patient-centric work culture
Excellent career growth opportunities in Drug Safety and Pharmacovigilance
Work on high-impact healthcare solutions that improve patient lives globally
Important Note for Applicants
This role is designed for experienced Pharmacovigilance professionals. Candidates with less than 3 years of experience or freshers may explore entry-level opportunities such as Drug Safety Associate, PV Associate, or Safety Data Analyst roles before applying for this position.
How to Apply
Interested candidates can apply through the official Roche Careers portal. For more verified global Pharmacovigilance, Clinical Research, Regulatory Affairs, Medical Writing, and Drug Safety jobs, visit ThePharmaDaily.com regularly.
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