Patient Safety Lead (Qualified Person of Pharmacovigilance)

Описание

Summary

The Patient Safety Lead implements and maintains 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. The role is accountable for ensuring oversights of all aspects of the local PV system including 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. The Patient Safety Lead also develops and implements local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the team of Patient Safety Partners to the Roche Pharma Vision.

Your Responsibilities

• 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.
• 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

Who You Are

• You are 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.
• You built 3 to 5 years of work experience in Pharmacovigilance, ideally within an affiliate setting, and knowledge on how decisions are made in the local and Global PV ecosystem.
• Advanced expertise in PV systems with the ability to design, implement, and maintain effective and compliant processes.
• You built deep understanding of the local environment and a proven ability to develop important partnership internally and externally, including influencing of, and negotiating with key personnel in an affiliate.
• You built good knowledge and understanding of new molecules / new therapeutic areas, digital health, data and insights; and you you built good understanding of other functions and pharma business, drug development, market access and PV, and ability to work cross-functionally as well as navigate through complexity.
• You bring a customer-centric mindset, with a deep understanding of the patient journey and how it connects to safety and regulatory frameworks.
• You bring strategic thinking, problem-solving skills, and the ability to manage both local and global priorities in a dynamic and changing environment.
• You bring a digital-first mindset and you are comfortable utilizing technology and resources to enhance patient safety efforts and drive innovation

NB! CV must be written in English, and only English CV’s will be considered