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The Position
Primary Accountabilities
- Implementation and 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
- Oversight of all aspects of the local PV system. 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
- Development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the team of Patient Safety Partners to the Pharma Vision
Key Responsibilities:
Enabling a Transparent & Effective Local PV System
- As part of the broader Safety organization, maintain holistic and comprehensive oversight of local PV compliance, including inspection readiness and act as the single point of contact for Safety, internally and externally, for safety-related aspects or as Qualified Person for Pharmacovigilance (QPPV), or similar, where required by the local regulatory authority
- 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 oversight/ activities include the following in line with Roche standard operating procedures:
- Management of Individual Case Safety Reports, Signal Detection & 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)
- Ensure the implementation of Roche Safety Vigilance in the Affiliate and drive mindset and behaviors to advance PV customer centricity and value for patients
- As an active member of the local ecosystem, lead 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
- 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
- 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)
- 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 (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)
- Drive the local 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
- Lead and partner to identify previously unmet safety needs, prioritize these needs and ensure delivery of outcomes through co-creation of solutions with local ecosystem partners, cross-country network and the Safety NET
- Proactively collaborate to generate 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
- Horizon scanning for trends / opportunities that enable acceleration and scalability of Patient Safety initiatives and patient solutions
Catalyze Self- Management of the Affiliate Patient Safety Team
- 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
- Pull in expertise and resources locally and from the Safety network as needed; and likewise, catalyze Patient Safety Partners’ strong contribution and engagement with the Safety NET as well as the wider Patient Safety Community. PtSL leads and/ or contributes meaningfully to high-priority work in the Safety NET
- Lead and empower local self-organizing Patient Safety Partners to identify shared purpose with stakeholders and leveraging this to co-create solutions as well as unlock possibilities for patients through Safety
- 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
Qualifications
- Passionate about Patient Safety, and understanding of Pharmacovigilance - may be a e.g. MD, HCP, PHD in life sciences, Master in Public Health / Pharmaceutical Medicine, etc
- MD/ HCP qualification is not a prerequisite, however, profile & qualification must meet local expectations (laws, regulations, stakeholders demands, etc.). E.g. countries that require MD or HCP qualification for QPPV or QPPV-like roles
Experience
- Experience relevant to PV in an affiliate setting (ideally, at least 3-5 years)
- Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development, clinical safety is considered advantageous
Technical Skills And Competencies
- Good knowledge and understanding of new molecules / new therapeutic areas, digital health, data and insights
- Experience and expertise in Pharmacovigilance and how decisions are made in the local & Global PV ecosystem
- Ability to design, implement, and maintain PV processes and PV oversight systems that are straightforward, effective, and efficient
- Good understanding of other functions & pharma business, drug development, market access and PV, and ability to work cross-functionally as well as navigate through complexity
- Deep understanding of the local environment and proven abilities to develop important partnership internally and externally, including influencing of, and negotiating with key personnel in an affiliate
- Strategic mindset, systems thinker, critical thinking skills and outcome-based planning
- Customer centric mindset with a strong understanding of patient journey(s), health systems and related Roche products/integrated healthcare solutions
- Understanding of affiliate priorities and global focus areas (e.g PHC, VBHC)
- VACC leadership growth-mindset (moving from the operational aspects to the development of safety strategy)
Visionary: inspire the Safety vision (int + ext). Catalizer: moving the ecosystem from PV reporting to Patient Safety.
Coach: support the team to think critically and increase safety awareness
- Digital mindset as second nature to communicate, and to utilize resources and expertise from the network to fulfill local needs
- Ability to contribute to the network with co-creation of solutions and share experiences. Able to simplify knowledge and adapt it to local needs
- Agility: ability to flex and thrive in a dynamic environment undergoing transformational change
- Externally focused: proactively monitors the external landscape to understand and communicate trends, competitive activity, risks and opportunities
Note: The role is based in Tunisia, covering Tunisia and Libya.
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.