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Patient Safety Partner
Job Location: Mumbai or New Delhi
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The Opportunity
You will be responsible for maintenance of an effective local PV system for the respective affiliate(s)/country(ies) to ensure ongoing compliance with global Roche and local legal / regulatory authority PV requirements.
You will support the oversight of the local PV system and this includes consistency in process execution, monitoring of the performance of the local PV system, proactive identification of actual or potential compliance gaps, and ensuring appropriate action is taken (including escalation to local and global senior management, as applicable) to prevent or resolve compliance issues.
You will develop and implement the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the Affiliate Patient Safety Team to the Pharma Vision.
Key responsibilities:
Enabling a Transparent & Effective Local PV System
Ensure local pharmacovigilance (PV) compliance and safety oversight by collaborating with global and local teams to drive safety activities such as safety reporting, risk management, and communication, while focusing on customer-centricity and improving patient safety and regulatory compliance.
Thought Partnership and Enablement to Advance Patient Safety Strategy
Act as a proactive safety expert, supporting patient-centric activities and projects (e.g., product launches) and co-creating solutions with affiliates and global functions to address patient safety needs, while contributing to and implementing the Patient Safety strategy and generating actionable safety insights.
Key areas of activities in line with Roche standard operating procedures include the following:
Individual Case Safety Reports, Signal Detection and Management for Local Products
Management of Aggregate Safety Reports, Pharmacovigilance Agreements, and Safety Data Exchange Agreements
Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, emerging safety issues)
Studies, Programs and Other business activities with implications to patient safety and PV Compliance (e.g., interventional CT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP)
Safety Labeling and PV Commitments
Local Pharmacovigilance System Master File (where applicable)
Who you are
You are someone with 10 years industry experience, with 3-5 years of affiliate Pharmacovigilance or other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information). Global clinical product development, clinical safety is considered advantageous. You are a MD, HCP, PHD in life sciences, Master in Public Health / Pharmaceutical Medicine, etc.
You have a patient centric mindset with a good understanding of patient journey(s), health systems and related Roche products/integrated healthcare solutions
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.