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Associate Director, Pharmacovigilance, Japac
3 months ago
The PPS (Pharmacovigilance and Patient Safety) 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 PPS organization, The Area PV Product Lead in JAPAC reports to the Area PV Product and Clinical Safety Head, JAPAC.
The APL position is accountable for providing medical teams (including Affiliate PV teams, Affiliate Medical Directors, Area Global Medical Affairs and other medical stakeholders), regulatory teams and other cross-functional partners with product safety insights that enable successful product launches, maximize value of on-market products and support product differentiation for asset value preservation.
Global safety strategies and local/regional PV experience are leveraged by APLs to deliver local/regional precision PV solutions in partnership with global, regional and local stakeholders.
Major Responsibilities:
Ensure launch readiness of Affiliate PV teams.
Tailor global PV launch materials to meet affiliate needs and drive PPS activities to prepare Affiliate PV teams for successful launches within their countries.
Facilitate Affiliate medical teams' understanding of benefit-risk position/messages and critical insights (e.g. safety topics discussed during dialog with regulatory agencies, post-marketing safety studies). Ensure readiness to implement post-marketing safety commitments. Share practical PV launch learnings across affiliates.Liaise with Affiliate/Area medical teams to proactively gather insights on regulatory and commercial strategies for late stage assets and provide PV perspectives.
Evaluate impact of these strategies on risk management planning and PV deliverables/activities. Connect with PPS and Affiliate PV Teams to share relevant information and ensure readiness to support strategies.Present product safety information at key regional leadership meetings and provide appropriate local context to inform local business decisions/activities.
Share local and area PV insights with PPS Safety Science leaders to inform Global PV strategies.
Provide Affiliate/Area medical teams with pertinent PV insights to support product differentiation and help preserve asset value and maximize product benefit-risk.
Provide consultation to International PV Operational Excellence team to optimize affiliate PV strategic planning and operational performance.Facilitate best practice sharing (e.g. successful approaches in engaging medical teams, insightful information that delivered high value to affiliates) across Area PV Leads and more broadly, across the International PV organization.
Required Education:
Bachelor's degree in a healthcare discipline (i
e:
Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines), Masters or advanced degree is desirable.
Required Experienc
e:
- 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 is required. Comprehensive knowledge of PV activities and deliverables, throughout the product lifecycle, required to support and maintain product benefitrisk profile. Ability to describe nature and communicate impact of these activities to other nonPV professionals.
- 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.
