Pharmacovigilance Cluster Lead – Egypt & Maghreb

Job Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVE:

• Manage the Pharmacovigilance (PV) relationship within the assigned Local Operating Companies (LOCs) to provide best PV support and functional expertise to the LOC(s) within the assigned territory, where applicable.
• Ensure compliance to applicable local legislations, company standards and procedures.
• Collaborate and liaise with PVAR ICMEA Area Lead and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system.
• In partnership with PVAR ICMEA Area Lead, defines and implements the local PV strategies as appropriate.

ACCOUNTABILITIES:

• Manages and oversees the PV system(s) in the assigned territory in accordance with local legislation and company requirements which may include but not limited to conducting safety reporting and submissions, trainings, PV agreements and obligations, risk management plan implementations, cross-functional engagements, organized data collection programs, PV vendor/supplier oversight and management, management and maintenance of GVP controlled documents using controlled document systems (electronic, or paper), etc. This may include working with PV suppliers where appropriate and ensuring a common understanding of the distribution of the PV responsibilities is in place.
• Works closely with the regional PVAR Liaison and ICMEA Area Lead to support and facilitate LOC PV interactions with other sub-functions of GPSE.
• Maintains appropriate stakeholder network with applicable Commercial BU, LOCs and R&D to facilitate and implement GPSE strategies in collaboration with PVAR ICMEA Area Lead, and serve as a liaison in the assigned territory to prevent gaps between Commercial BU, R&D functions and GPSE.
• To be the SME of their assigned territory as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors.
• Establish and support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers, if applicable.
• With support from Regional Process and Compliance Lead, and PVAR ICMEA Area lead, assist with audit/inspection preparation and lead the audit/ inspection within the assigned territory. Responsible for CAPA initiation and closure within the assigned territory.
• Communicate all potential safety issues within the assigned territory immediately to GPSE, GEM Region Head, PVAR liaison and ICMEA Area Lead as appropriate.
• Support LOC(s) within assigned territory, where applicable in collaboration and agreement with the appointed Area Lead.
• Perform local QPPV and/or local PV contact person activities where required and trained to do so.
• Support LOC PV operations and assumes the role of Patient Safety Lead (PSL) / Drug Safety officer (DSO), PSL/DSO delegate, deputy or backup as necessary.
• Line manage PV resources where appropriate.

EDUCATION, EXPERIENCE AND SKILLS:

• Health professional of life science degree
• Bachelor’s required. Advanced degree preferred
• Relevant pharmaceutical or health care related industry experienced required
• Meets all applicable local QPPV / PV contact person requirements including education, training, experience
• Advanced experience, generally with at least 5 years in PV related environments, preferably at local, regional and/or global levels
• Understanding of medical/scientific terminology
• Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
• Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
• Excellent written/oral communication skills (local language, English [mandatory] & French [preferable]) and experience working within virtual teams
• Accuracy and attention to detail
• Flexible mindset
• High degree of cross-cultural awareness
• Team worker with collaborative approach
• Ability to prioritize under pressure
• Decision making capability, and ability to independently resolve problems and conflicts
• Well-developed organizational skills

Locations

Worker Type

Worker Sub-Type

Time Type