Associate Director, Pharmacovigilance Affiliate Liaison, GEM Region応募 後で応募 求人ID R0015626 掲載日 12/24/2019 Location:Singapore, Singapore
- Manage the Pharmacovigilance (PV) relationship with local operating company (LOC) PV personnel within the assigned territory to best support the PV function.
- Collaborate and liaise with Global Patient Safety Evaluation (GPSE) functions to ensure appropriate systems and processes are in place to support PV locally, regionally and globally.
- Provide PV functional expertise and support to LOCs.
- In partnership with GPSE functions, leads, facilitates and executes local, regional and global strategies as appropriate.
- Works across assigned area to support and facilitate LOC PV interactions with other sub-functions of GPSE.
- Works with Region Head to implement global, regional and local PV strategies at the LOCs.
- Maintains appropriate stakeholder network with Commercial, LOCs and R&D to facilitate implementation of GPSE strategy and support the Region Head to serve as a liaison in their assigned territory to prevent gaps between Commercial and GPSE.
- To be the SME of the assigned territory as it relates to regulatory requirements, resourcing, compliance and other factors.
- Supports Affiliate PV Process and Compliance in undertaking impact analysis of PV-related regulatory changes; changes to local, regional and global procedures; or Takeda policies on local, regional or global PV system.
- Contribute to and manage assessment of LOC PV training needs and facilitate support for LOC PV training with active involvement/resource allocation as needed.
- Responsible for execution on EU QPPV (and, if appropriate local QPPV) requirements supporting oversight for PV systems in LOCs.
- Maintains Descriptions of Pharmacovigilance Responsibilities (DPRs) with LOC DSOs to provide official record of GPSE and LOC delegation of responsibilities.
- Work with Cluster Leads, Process and Compliance Leads, Vendor Management / Oversight personnel and LOC DSOs in support of LOC PV audits and inspections, including follow-up and CAPA management.
- Ensure close collaboration with Process and Compliance Leads in ensuring quality assurance and compliance disciplines—globally, regionally and locally—to best support LOC needs.
- Support and advise the Cluster Leads and DSOs on the development / maintenance of PV systems in LOCs and facilitate, as appropriate, local PV SOPs.
- Works with Region Head, Cluster Leads, Process and Compliance Leads, Vendor Management / Oversight personnel and other stakeholders to facilitate best practice sharing and ongoing process improvement and identification of process efficiencies.
- Ensures all contact information and any changes of LOC PV personnel are maintained for GPV communications.
- Support Vendor Oversight Leads with vendor oversight strategy and approach development and execution.
Geographic Scope of Responsibility:
- SAM – South Cone, Andean Cluster, Mexico and Central America
- ICMEA – India, Central and Eastern Europe, Middle East and Africa
- APAC – Taiwan, Korea, Southeast Asia and Oceania Cluster
Education and Experience
- Bachelor degree required, preferably in life sciences. Advanced degree preferred.
- Extensive pharmaceutical or healthcare-related industry experience required, or experience as a health professional (nursing, etc).
- Advanced experience in PV-related environments, preferably at local, regional and/or global levels.
- Excellent knowledge of PV regulations for the post-marketing global environment and regional legislation in particular.
- Understanding of medical and scientific terminology.
- Experience working within virtual teams.
Skills, Competencies and Behaviors
- Excellent written / oral communication skills.
- Accuracy and attention to detail.
- Flexible mindset.
- High degree of cross-cultural awareness.
- Team worker with collaborative approach.
- Ability to prioritize under pressure.
- Well-developed organizational skills.
- High standard of computer literacy.