Working Location: Binh Thanh District, HCMC

Working Hours: 9:00 AM - 6:00 PM, Mon - Fri

Job purposes/Job summary:

• Implementation and maintenance of an effective local PV system for the respective affiliate(s) 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.
• This role will work 0.5 FTE for the Vietnam affiliate Patient Safety and 0.5 FTE for the Korea affiliate Patient Safety. The resource allocation and supporting countries can be flexible per the Safety network needs (The relevant affiliate Patient Safety Leads will act as dotted line managers, including, but not limited to, assigning the affiliate duties, providing relevant training/guidance, and offering performance feedback).

Essential Duties and Responsibilities:

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 
• Management of Aggregate Safety Reports, Pharmacovigilance Agreements, and Safety Data Exchange Agreements 
• Risk Management and Safety Communication 
• Studies, Programs, and Other business activities with implications to patient safety and PV Compliance ·
• Safety Labeling and PV Commitments

Support the implementation of the Roche Safety Vigilance in the affiliate and drive mindsets and behaviors to advance PV customer centricity and value for patients.

Connect with local 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. 

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 strategy. 

Ensure business continuity and collaborate with line management, and cross-country network.

Education and Qualification: 

• Minimum bachelor’s degree, a qualified healthcare provider (pharmacist, nurse) is preferred. 
• Passionate about Patient Safety with understanding of Pharmacovigilance. 
• Experience at least 2 years in Pharmacovigilance / Patient safety or other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development or safety 
• Experience in working effectively and collaborating in a virtual setting. Other skills & abilities 
• Languages: Proficient in English and Vietnamese, ability in Korean is beneficial. 
• Sound communication skills 
• Learning agility and ability to adapt to changes. 
• Works effectively, independently and collaboratively as a team player in a multi-disciplinary environment. 
• Strong accountability and ownership. Ability to work independently under pressure and convey a sense of urgency. 
• Problem solving skills and critical thinking