Patient Safety Partner at Roche

The key responsibilities includes though not limited to: 

• Support the Roche Pharmacovigilance system Compliance
• Through ensuring that relevant processes are documented, monitored and improved in compliance with legal requirement
• Through the timely submission of Pharmacovigilance-related documents in accordance with statutory requirements. To ensure the required quality, accuracy and completeness of the PV data submitted to the competent authority in assigned regions
• To provide support in preparedness for Pharmacovigilance inspections
• Through the access to Pharmacovigilance system Masterfile, verify that the information contained therein, is an accurate and up-to-date reflection of the PV system 
• Through implementation and maintenance of an effective Pharmacovigilance system to ensure ongoing compliance with global Roche and local legal / regulatory authority PV requirements.
• Oversight of the Risk/Benefit Profile of Approved Roche Medicinal Products
• Possess adequate and up-to-date knowledge of regulatory requirement relating to safety or the safe use of approved products
• Ensure a complete and timely response to the requests of the competent authority in assigned regions to supply additional information needed for the benefit/risk evaluation of the medicinal product
• Ensure submission of RMPs upon request and Periodic Safety Update Reports as per schedule to the competent authority
• Provide support in the oversight of risk/benefit management activities and emerging safety concerns
• Collaboration with Internal and External Interfaces
• 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
• 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
• 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
• 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
• 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) 
• Horizon scanning for trends and opportunities to enable acceleration and scalability of Patient Safety initiatives and patient solutions
• 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 
• Act as a trusted point of contact for Global Safety, the network, the Hub and be the point of contact for  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 Healthcare practitioners(HCPs) through primary points-of-contact and channels)

Qualifications 

• Passionate about Patient Safety, and understanding of Pharmacovigilance - may be 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).  

Experience 

• Significant experience in Drug Safety particularly operational PV plus qualification per training
• Experience in Medical function (e.g., Medical Affairs, Clinical Operations, Medical Information etc) of a biopharmaceutical company preferred 

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
• Strong communication skills
• Language: Fluent in oral and written English​