Job Description: Patient Safety Partner
Company: Roche
Location: Mumbai or New Delhi
Category: Pharmacovigilance / Patient Safety
About Roche
Roche is a global leader in healthcare, driven by a mission to create a healthier future through innovation and inclusivity. We celebrate diversity and believe that equity and inclusion are vital for understanding and addressing the varied healthcare needs of communities worldwide. At Roche, every voice matters, and every contribution counts.
Join us and become part of a team that is reshaping the future of healthcare.
Position Overview: Patient Safety Partner
Purpose of the Role
As a Patient Safety Partner, you will ensure the maintenance and oversight of an effective local pharmacovigilance (PV) system for the respective affiliate(s) or country(ies). Your role will focus on compliance with global Roche and local regulatory PV requirements while supporting the development and implementation of a local Patient Safety strategy.
Through your contributions, you will enable a safer patient experience, foster collaboration across global and local teams, and drive the integration of safety insights into Roche’s broader pharmaceutical vision.
Key Responsibilities
Ensuring Effective Local PV System
Maintain PV compliance through collaboration with global and local teams.
Execute safety activities such as risk management, safety reporting, and regulatory communication.
Monitor the performance of the local PV system, identifying compliance gaps and implementing corrective actions as needed.
Escalate compliance issues to local and global senior management as required.
Advancing Patient Safety Strategy
Serve as a safety expert, contributing to patient-centric activities like product launches and risk communication.
Co-create solutions with global and affiliate functions to address patient safety needs.
Implement the Patient Safety strategy and generate actionable safety insights to enhance compliance and patient outcomes.
Key Activities
Individual Case Safety Reports (ICSRs): Manage local safety reporting and signal detection.
Aggregate Safety Reports: Ensure compliance with the preparation and submission of periodic safety reports.
Risk Management: Develop and communicate safety measures, such as Direct Healthcare Professional Communications and addressing emerging safety issues.
Studies & Programs: Provide safety oversight for clinical trials, non-interventional studies, post-authorization safety studies, and other patient assistance programs.
Safety Labeling & Commitments: Ensure compliance with safety labeling changes and pharmacovigilance (PV) commitments.
Pharmacovigilance Agreements: Oversee safety data exchange agreements and maintain the Local Pharmacovigilance System Master File, as applicable.
Qualifications & Experience
Education:
MD, HCP, PhD in Life Sciences, or a Master’s in Public Health/Pharmaceutical Medicine.
Experience:
10+ years in the pharmaceutical industry.
3–5 years in affiliate Pharmacovigilance or other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information).
Experience in global clinical product development or clinical safety is advantageous.
Skills & Competencies:
Patient-centric mindset with a deep understanding of patient journeys and healthcare systems.
Expertise in Roche products and integrated healthcare solutions.
Proactive problem-solving and collaboration across global and local teams.
Why Roche?
Innovative Impact: Be part of a global team at the forefront of healthcare innovation.
Diversity & Inclusion: Work in an inclusive environment that values individuality and promotes equity.
Professional Growth: Grow your career while contributing to life-changing healthcare solutions.
At Roche, we believe in creating a workplace where everyone feels empowered to bring their best. Join us to make a meaningful difference in healthcare.
Roche is an Equal Opportunity Employer.
We are committed to fostering diversity and inclusion in the workplace. All qualified applicants will receive equal consideration regardless of race, gender, disability, or other characteristics protected by law.
Apply Today:
Join Roche and help us shape the future of healthcare for generations to come.
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