Patient Safety Partner

The Position
Summary
The Patient Safety Partner serves its purpose as follows:
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 Local Security Responsible to Patient
Safety Partner, 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 bottlenecks.
Your responsibilities
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. 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. 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) .
‎5. 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.
‎6. As an active member of the local ecosystem, contribute to 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.
Catalyze Self-Management of the Affiliate Patient Safety Team
Ensure business continuity and collaborates with line management, and 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;
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 the generation
of additional safety insights.
Skills and Knowledge
* 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 partnerships 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).
* Agility: ability to flex and thrive in a dynamic environment undergoing transformational change
* 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.
* Externally focused: proactively monitors the external landscape to understand and communicate trends, competitive activity, risks, and opportunities
Educational Background and Qualifications
Qualifications
* Passionate about Patient Safety, and understanding of Pharmacovigilance
* A minimum of Bachelor degree of pharmacy or medicine
* Ability to communicate clearly and accurately in both written and spoken English and Arabic.
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.
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.