Job title: Patient Safety Partner
Job description: The Position
Enabling a Transparent & Effective Local PV System
1. As part of the broader Safety organization, support the holistic and comprehensive oversight of local PV compliance, including inspection readiness and act as deputy point of contact for Safety, internally and externally, for safety-related aspects or as deputy Qualified Person for Pharmacovigilance (QPPV), or similar, where required by the local regulatory authority. The Patient Safety Partner may be designated as the Deputy of the Patient Safety Lead within the Affiliate, or another country. 2. Active contribution to the efficient, high-quality operational execution of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of Roche products and their safety risk management, meet regulatory requirements, and ensure license to operate. 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)
3. Support the implementation of the Roche Safety Vigilance in the Affiliate and drive mindset and behaviors to advance PV customer centricity and value for patients. 4. As an active member of the local ecosystem, contribute in shaping and influencing the local safety regulatory environment driving towards safer and robust healthcare systems, working with partners such as local pharma industry associations, healthcare organizations, patient and patient groups etc.
Thought Partnership and Enablement to Advance Patient Safety Strategy
5. Connect with ecosystem partners and understand the wider Affiliate priorities (e.g., Outcome Based Planning), co-create solutions and drive Safety partnership with affiliate and global functions to address customer safety needs. 6. Proactive safety expert support as a thought partner for patient-centric activities and projects, including product launches, precision medicine and other strategic affiliate activities (e.g., Safety data and insights, safety risk management, adequate PV oversight on local data generation and RWE activities) 7. Act as a trusted point of contact for Global Safety, the network, the Hub and be the point of contact for PJP/HSP and local colleagues for safety expertise for the assigned Disease Area or Therapeutic Area (e.g., co-create and have oversight of PV safety communication to external stakeholders including the communication of the right safety information to the right audience at the right time through the right channel in a transparent manner to address the identified and emerging needs of patients and HCPs through primary points-of-contact and channels) 8. Contribute and implement the Patient Safety strategy working in close collaboration with the other functions (e.g. Medical, Access, PJP/HSP etc) as part of the integrated disease area or therapeutic area strategy and set priorities based on local business needs, customer expectations, portfolio/ disease area focus. 9. Anticipate and partner to proactively identify previously unmet safety needs and to co-create and drive the local Safety strategy aligning global safety strategy, in partnership with the Safety NET, and taking into account prioritized local needs, and deliver on these outcomes 10. Proactively collaborate to generates actionable safety insights that matter to patients, HCPs and the business, supporting e.g. safe home treatment, HTA discussions, safety launch readiness especially for new disease areas where safety needs are particularly complex and high 11. Horizon scanning for trends and opportunities to enable acceleration and scalability of Patient Safety initiatives and patient solutions
Catalyze Self- Management of the Affiliate Patient Safety Team
12. Ensure business continuity and collaborates with line management, cross-country network on resource activities to ensure appropriate prioritization and resource allocation to deliver key focus areas and outcomes, and provide feedback to ensure the right skills and expertise are deployed to the team 13. Pull in expertise and resources locally and from the Safety network as needed; and likewise, flow to high priority work and contribute expertise as part of the Safety NET to co-create solutions as well as unlock possibilities for patients through Safety 14. Drive continuous improvement of local safety capabilities in operational PV and safety science expertise, including the ability to apply safety insights in the local context. Among others, this may include activities to enhance the safe use of Roche medicinal products, treatment outcomes, patient experience, effective safety communication, fit for purpose risk minimization, product launch support, product access, and generation of additional safety insights.
Who we are
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.
Location: Mumbai, Maharashtra
Job date: Thu, 14 Jul 2022 22:35:54 GMT
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