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Location: Almaty, responsibility area for Kazakhstan and Belarus

Reporting line: Patient Safety Country Cluster Lead

Job Purpose: 

Visionary: Inspiring the Safety vision (internally and externally), creative leadership, living the Roche Operating Principles, supporting transparency, consistency and co creation to advance the safety vision in the Affiliate and the network 

Architect: Evolves the role of Patient Safety Partner, and empowered to make great decisions, enable action, as well as create a pull system within the network based on flow, transparency and trust 

Coach: Helps everyone in their network to build the skills and mindset they need to succeed; coaching and being coached 

Catalyst: Removes obstacles, prioritizing to create clarity and focus; collaborates internally and externally to solve PV system bottleneck

Primary Responsibilities and Accountabilities 

Implementation and maintenance of an effective local PV system for the respective affiliate(s)/country(ies) (Belarus and Kazakhstan) to ensure ongoing compliance with global Roche and local legal / regulatory authority PV requirements.

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. 

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, 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. 

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)

Note: Depending on country set-up and end-to-end process support by the PV Hub, the Patient Safety Partner may be primarily responsible, or involved in parts of operational execution of the above procedural areas, in accordance with Roche standard operating procedures.

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. 

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

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 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) 

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. 

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 

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 

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 

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, 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 

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. 

Professional and Technical Requirements:

Education/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, Skills, Knowledge:

Experience

Experience in PV particularly in an affiliate setting (ideally, at least 1-3 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). 

Catalyzer: 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

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.