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The PositionAffiliate: Roche Pharma Korea

Medical Partnership Cluster

Work location: Seoul, South Korea

Worker Type: 1 year contractor

Your key responsibilities

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 Labelling 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.
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.
5. Any specific roles according to global requirements (e.g., RMP Implementation Coordinator, DHPC Coordinator, PV approver, Digital Customer Engagement and Listening Activities (DiCELA) Champion, etc.) or regulatory requirements (e.g. Safety Control Manager 안전관리책임자) can be assigned as needed. Documentation of the role assignment and description of the detailed responsibilities will follow the Roche global procedures or Korean regulatory requirements.

Thought Partnership and Enablement to Advance Patient Safety Strategy
6. 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.
7. 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)
8. 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)
9. 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.

10. 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
11. 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
12. 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
13. 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

14. 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
15. 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 you are

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

● 3+ years of relevant experience preferred
● Experience in PV particularly in an affiliate setting
● 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).
○ Cathalizer: 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

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Submission

자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출)

※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.

※ 이력서 내 이메일 주소와 서류전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다.

※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다.

※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오.

※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다.

Process

서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격 통지

※ 면접은 서류전형 합격자에 한해 개별 통보합니다.

※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.

※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.