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Job Description

Objective of Role:

• Responsible for overseeing the quality management and compliance activities as they relate to post market safety of the applicable affiliate office(s) in the I-SEA Area.

• Supports and provides audit/inspection readiness and pharmacovigilance oversight, functional expertise and leadership to the Cluster and/or Country Leads within the assigned area.  

• Works in partnership with GPSE and GVSE to ensure systems and processes are in place to best support and ensure regulatory compliance for PV locally, regionally and globally where Takeda holds MAH / markets products.  

• Works in partnership with other local, regional and global stakeholders (R&D, I-SEA BU and where applicable external vendor(s)) to ensure oversight and support of the PV system.

• Acts as point of contact for any safety related issues and escalation in the one of the Clusters or Country in the I-SEA Area.

Accountabilities:

• Accountable and responsible for aligning and co-coordinating PV activities across the Clusters/ Countries in I-SEA Area

• Develops the pharmacovigilance capabilities across the I-SEA Area

• Manage cluster / country PV resources, including PV vendors and works with direct reports on ensuring appropriate capability development requirements are defined and actioned including goal setting, performance management, team guidance and training 

• Ensures PV compliance with required PV regulations across I-SEA Area

• Works with PV Cluster/ Country leads to set the goals, priorities, key performance metrics and long-term plans within the respective Cluster/ Country in the I-SEA Area

  • Appropriate resourcing / outsourcing strategies 

  • Meets regulatory requirements and compliance  

  • Sets training priorities  

• Guides and provides support to the Cluster/ Country for implementation of specific Pharmacovigilance Strategy (aligned with Global and / or regional where applicable)  

  • Identifies synergies and best practice sharing across LOCs  

• Ensure PV systems and procedures are appropriately implemented / functioning across the country or local affiliate offices within the I-SEA area

  • Responsible for oversight and support in implementation of Cluster and/or Local SOPs where needed  

  • Oversee Global SOP Implementation at LOC level  

  • Oversee adherence Compliance to Local PV Regulations and applicable regional, and global requirements  

• Responsible for issue escalation within and external to PVAR Head for GEM as required 

• Responsible to cascade relevant PV information (e.g. global, regional and area) to key stakeholders (E.g. Medical Affairs, Regulatory Affairs, Quality Assurance, Compliance) for full alignment in support of corporate goals and in support of business needs.  

• Establish and maintain strong relationships with key stakeholders to promote PV and Patient Safety  

• Provide leadership to PV Cluster and Country Leads and /or Patient Safety Leads 

• Facilitate and contributes to the development of career path opportunities for local PSLs within their cluster / country

• Support the PVAR Patients Access Lead in I-SEA Area Access Markets in to ensure Patient Safety in donations programs and PAP and work with the Patient Access Lead to establish PV communication platform where needed

• Work with PVAR vaccines Lead and GVSE and provide expert insight to support in discussions with National Health Authority (where applicable) and internal key stakeholders around Vaccines Safety, oversee and work with PVAR LOC in support of the launch of vaccines in the I-SEA region and post marketing commitments. In alignment with PVAR Vaccines Lead and GVSE, support and guide LOCs around Vaccines Safety communication strategy in I-SEA region.

Education, Experience and Skills:

• Bachelor’s required. Health professional (nursing etc) or life science degree and/or advanced degree preferred.

• Extensive pharmaceutical or health care related industry experience required

• Advanced experience in PV related environments, preferably at local, regional and/or global levels

• Advanced experience of working cross-functionally

• Understanding of medical/scientific terminology

• Excellent knowledge of PV regulations for the post marketing global environment and regional legislation in particular

• Excellent written/oral communication skills and experience working within virtual teams.

• Experience of a mixed resource model and/or vendor management preferred;

• Experience of line management preferred

• Accuracy and attention to detail

• Flexible mindset

• High degree of cross-cultural awareness

• Team worker with collaborative approach. 

• Ability to prioritise under pressure

• Well-developed organizational skills

• High standard of computer literacy

Travel Requirements:

• Some travel is expected within the India-South East Asia region

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