Job Description: Patient Safety Partner
Company: Roche Diagnostics India
Location: Mumbai or New Delhi
About Roche
At Roche, we are driven by a passion for advancing healthcare and improving patient outcomes. Diversity, equity, and inclusion are at the heart of what we do, ensuring that we reflect and serve the communities we work with. Join us and become part of a team that works towards creating a healthier future for generations to come.
Position Overview
As a Patient Safety Partner, you will be responsible for maintaining an effective local pharmacovigilance (PV) system to ensure ongoing compliance with Roche’s global safety requirements and local regulatory standards. You will actively support local and global teams to drive safety activities, manage risks, and improve patient safety. Your work will focus on creating transparent safety processes and contributing to the global Pharma Vision through proactive safety strategies and activities.
Key Responsibilities
Local Pharmacovigilance (PV) System Oversight:
Ensure compliance with local PV and safety regulations by working closely with global and local teams.
Support safety activities such as safety reporting, risk management, and communication to improve patient safety and regulatory compliance.
Proactive Safety Leadership:
Act as a safety expert in various activities and projects, including product launches, ensuring patient safety is at the core of all processes.
Co-create solutions with affiliates and global functions to address safety needs, contributing to Roche’s overall Patient Safety strategy.
Develop actionable safety insights that support both local and global initiatives.
Management of Safety Reports & Agreements:
Oversee the management of Individual Case Safety Reports (ICSRs), signal detection, and aggregate safety reports for local products.
Ensure timely and accurate management of Pharmacovigilance Agreements and Safety Data Exchange Agreements.
Risk Management and Safety Communication:
Lead Risk Management activities and Safety Communication (e.g., Direct Healthcare Professional Communication, emerging safety issues).
Ensure compliance with Roche's Safety Labeling and PV Commitments.
Support to Studies and Programs:
Provide safety oversight for studies, programs, and business activities impacting patient safety and PV compliance (e.g., interventional clinical trials, observational studies).
Ensure patient safety considerations are integrated into clinical, medical, and regulatory activities.
Local PV System Master File Management:
Ensure that the Local Pharmacovigilance System Master File is maintained in accordance with Roche and regulatory standards, where applicable.
Qualifications & Experience
Education:
MD, PhD in Life Sciences, Master in Public Health, Pharmaceutical Medicine, or a related field.
Medical Doctor (MD) or equivalent healthcare professional background is advantageous.
Professional Experience:
10 years of industry experience, with 3-5 years in affiliate Pharmacovigilance or other medical functions such as Medical Affairs, Clinical Operations, or Medical Information.
Experience in global clinical product development and clinical safety is considered a plus.
Skills & Competencies:
Strong understanding of the patient journey, healthcare systems, and Roche’s integrated healthcare solutions.
Demonstrated ability to work in cross-functional teams, driving safety initiatives and managing compliance.
Excellent communication and collaboration skills, with the ability to engage stakeholders at all levels.
Why Join Roche?
At Roche, we are committed to pushing the boundaries of healthcare. With over 100,000 employees across 100 countries, we are one of the world's leading research-focused healthcare groups. Our focus on innovation, curiosity, and diversity ensures that we can provide transformative healthcare solutions that improve lives. Join Roche and help make a difference!
Roche is an Equal Opportunity Employer.
We welcome diverse candidates and are committed to fostering an inclusive work environment where every voice matters.
Apply Now to become a Patient Safety Partner and help us create a healthier future for all!
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
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