Local PV Product Safety Head, China
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The PSQ (Pharmacovigilance & Patient Safety, R&D Quality Assurance) organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our products to protect patients worldwide.
Within the PSQ organization, the Local PV Product Safety Head (LPSH), China, reports to the Area PV Product and Clinical Safety Head, JAPAC (APCSH).
The LPSH plays a pivotal role in leading the creation and execution of local strategic safety priorities in partnership with the APCSH and different cross-functional teams across clinical development, regulatory affairs and medical affairs. With their clinical safety expertise, the LPSH serves as the local strategic safety advisor, delivering high quality safety insights throughout the product’s development lifecycle to enhance patient safety, maximize the success of development programs & regulatory approvals.
- Provide strategic safety leadership by leading local strategic safety discussions, integrating China-specific safety needs to drive the success of development products and on-market benefit/risk assessments. Deliver critical safety insights to affiliate clinical development and medical teams to elevate understanding of benefit-risk positions and key safety messages. Leverage these shared insights, learnings and experiences to extend safety leadership across other countries in JAPAC, supporting AbbVie’s geostrategy to expand its clinical development footprint.
- Define and execute the LPSL China strategy in collaboration with the APCSH, aligning with AbbVie’s overall China R&D strategy and addressing the evolving business needs.
- Serve as the primary point of contact for senior cross-functional leaders locally and globally on matters related to patient safety for China.
- Establish and nurture strategic partnerships and scientific connections with key stakeholders within Affiliate/Area and global teams. Proactively gather insights on safety, regulatory and global strategies for development and late stage assets. Provide PV/clinical safety expertise and evaluate impact of these strategies on risk management planning and PV deliverables/activities. Align safety strategies with business objectives within PSQ and across affiliate teams and ensure readiness to support these strategies.
- Deliver expert guidance in developing comprehensive safety deliverables and actively participate in local Health Authority review boards and meetings as necessary.
- Lead and manage LPSL Oncology in China, aligning with global oncology safety strategy and local country specific needs.
- Demonstrate local safety leadership in early development by leading the integration of safety considerations into early development studies tailored to the China market. Effectively guide and support the analysis, interpretation and summarization of clinical safety data from China studies and facilitate the clear communication of these to relevant cross functional teams and senior management.
- Leverage deep understanding of local regulations to shape the strategic direction for product/device submissions/approvals, effectively addressing regulatory questions.
- Present and share valuable safety insights with PSQ Safety Science Leaders and at key affiliate, regional and global meetings, providing local context to inform global strategic business decisions and activities.
- Promote knowledge sharing and training initiatives to foster professional development and best practices across China, Area PV Product Leads and the broader International PV and PSQ organization. Actively engage in coaching and mentoring team members and colleagues.
Qualifications
- At least 7 years’ experience working in the healthcare industry and a strong understanding of the drug development and drug licensing process.
- Extensive experience within Pharmacovigilance in Medical Safety is required (e.g., Medical Safety Physician). Comprehensive knowledge of PV/Medical Safety activities and deliverables, throughout the product lifecycle, required to support and maintain product benefit-risk profile.
- Ability to understand product’s safety profile and put this into local medical context to anticipate and mitigate potential safety considerations and issues.
- Understanding of the connections between regulations and science for the benefit of drug safety
- Strong leadership presence and strong communication/presentation skills.
- Proven ability to effectively communicate and synthesize pertinent information in a clear and impactful manner to senior executives.
- Ability to connect the dots quickly between strategies and decisions; skilled in asking the right questions and proactively anticipating information needed to inform business decisions/actions.
- Ability to work collaboratively with colleagues across organizational boundaries. Ability to quickly build trusted relationships in affiliates, at a regional/area level, across therapeutic areas, etc.
- High degree of strategic thinking and demonstrated problem solving skills;
- resourcefulness and initiative to access/find information; ability to think quickly on his/her feet.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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