Patient Safety Partner

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Affiliate: Roche Pharma Korea

Medical Partnership Cluster

Worker Type: Permanent

Work location: Seoul, South Korea

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 ther