We are seeking a strategic and collaborative Patient Safety Asia 5 Regional Lead, to perform the local Patient Safety Lead role in Hong/Macau and in Singapore as well as be responsible for oversight of patient safety activities in the Asia 5 region which includes Hong Kong/Macau, South Korea, Taiwan, Singapore, and Malaysia. This role will also be responsible for assisting the Patient Safety Affiliate Leadership Team to ensure overarching integration of the China and Japan Patient Safety teams within the Asia region. As the Patient Safety Asia 5 Regional Lead, you will play a crucial role in shaping our patient safety strategy for these key Asian markets with a focus on influential cross functional partnering and bringing local insights with regards benefit-risk and patient-centricity into the global product safety evaluation. Leveraging your expertise in regional regulations, Authority expectations and industry trends, you will collaborate closely with cross-functional teams and external partners to enhance drug safety initiatives & visibility, regulatory compliance, and patient care.
Example Responsibilities:
· Perform the Affiliate Head of Patient Safety (AHoPS) role for Hong Kong/Macau and Singapore.
o Critical point of contact for authority on safety matters.
o Trusted and strategy partners providing input to global teams, industry and to the local business.
o Patient centric focus decision making.
o Pro-active local leadership & forecasting.
· Develop and execute patient safety strategies within the Asia 5 markets with a patient-centric approach, ensuring alignment with local regulations, cultural nuances, and business objectives.
· Provide strategic guidance and direction to cross-functional teams on patient safety considerations throughout the product lifecycle.
· Ability to identify and communicate potential safety risks associated with our products in the Asia 5 markets and provide input into the global benefit-risk evaluation.
· Cultivate collaborative relationships with regulatory authorities, industry organizations within the region to influence patient safety policies and promote patient-centricity in pharmacovigilance practices.
· Drive continuous improvement initiatives to enhance patient safety processes, systems, and capabilities in the Asia 5 region, leveraging data analytics and innovative technologies.
· Serve as a subject matter expert on patient safety regulations and guidelines specific to the Asia 5 markets, providing strategic guidance and training to internal stakeholders as needed, with a focus on fostering a patient-centric culture within the organization.
· Collaborate with Medical Affairs, Regulatory Affairs, and other relevant functions to ensure alignment of patient safety strategies with broader business objectives and regulatory requirements in each market.
· Represent the company in patient safety audits, inspections, and other regulatory interactions specific to the Asia 5 markets, ensuring timely responses to findings and implementation of corrective actions.
· Monitor and assess the impact of changes in patient safety regulations and guidelines in the Asia 5 markets, proactively adapting strategies, and processes to maintain compliance and mitigate risks.
· Contribute to the development of patient safety-related communications tailored to each market, including safety assessments, risk management plans, and regulatory submissions, with a focus on transparency, patient engagement, and empowerment.
Qualifications:
· Degree in pharmacy, life sciences, or a related field.
· Broad and long-term experience in pharmacovigilance within the pharmaceutical industry.
· Excellent communication, collaboration, and influencing skills, with experience building effective relationships with internal and external stakeholders in the region and prioritizing patient perspectives.
· Demonstrated leadership abilities, including the ability to inspire and motivate cross-functional teams to achieve common goals in the Asia 5 markets.
· Experience in patient safety auditing, inspection readiness, and regulatory interactions specific to the Asia 5 markets is highly desirable.
Knowledge & Other Requirements:
· Proven track record of developing and implementing patient safety strategies in the Asia 5 markets, with deep understanding of regional regulations, guidelines, and industry standards.
· Strong strategic thinking and analytical skills, with the ability to translate complex data and insights into actionable recommendations for the Asia 5 markets.
· Proven ability to thrive in a dynamic and fast-paced environment, managing multiple priorities and driving results with a sense of urgency.
· Strong negotiating and conflict resolution.
· Coaching capabilities.
· Prepared to travel as required.
