Job Title :
Regional Vendor Oversight Lead
Function : GPSE
PV Affiliate Relations
Reports To (Title) :
Snr Director, Regional Affiliate Relations
This role is responsible for supporting and overseeing local and regional vendor oversight model for the LOCs in collaboration with GPSE Vendor Oversight function.
This includes managing regional vendor relationship / s, ensuring a harmonized LOC vendor model that complies with regulatory, procedural or contractual requirements across the appointed region.
Additionally, this role supports implementation of LOC PV regional vendor model where applicable.
Ensure LOC PV vendor oversight process is harmonized and inspection ready for local PV Systems
Ensure a regional vendor oversight model is established and maintained which optimizes LOC PV vendor management and oversight in collaboration with GPSE Vendor Oversight team
Represent LOC PV vendor oversight requirements in applicable forums and initiatives to ensure the LOC PV needs are understood and actioned
Establish / participate and where appropriate lead regional vendor governance and relationship management activities
Work in close collaboration with GPSE, ensuring alignment with the global PV vendor oversight strategy.
Identify, plan and execute regional and local vendor oversight harmonization initiatives that drive further alignment, harmonization, efficiency and inspection readiness in collaboration with LOC PV and broader GPSE community
Undertake analysis of regional PV vendor management and oversight activities to identify improvement opportunities, level of existing oversight, gaps / risks that require further management and / or escalation and build and execute a vendor oversight model that ensures a harmonized oversight model that is effort efficient and effective.
Ensure vendor oversight and approaches are compliant with related processes, policies and regulatory requirements locally, regionally and globally.
Ensure any vendor oversight tools are utilized efficiently and consistently across LOCs
Identify and track optimal vendor oversight metrics, data sources and reporting opportunities that will ensure timely, accurate and harmonized oversight of vendors that meet local, regional and global oversight requirements in collaboration with GPSE Vendor Oversight function
Support PV LOC audit / inspection activities related to vendor oversight, including preparation, audit support, and post-audit activities related to vendor oversight and management in close collaboration with PV Compliance, PV Affiliate Liaison and LOC PV and quality teams
Responsible to define and disseminate regional vendor oversight best practices
Ensure close collaboration with GPSE and R&D vendor oversight functions to best support LOC needs.
Ensure local and / or regional PV processes are in place to clearly define PV vendor oversight responsibilities within the LOCs in line with Global SOPs and local regulations.
Support and advise on the development / maintenance of PV vendor oversight in LOCs and facilitate, as appropriate, local PV vendor oversight Training
Interfaces with Commercial teams and GPSE to facilitate smooth business partners relations / Alliance management to successfully address any activities related to pharmacovigilance agreements (PVAs) / Safety Data Exchange Agreements (SDEAs) that impact and / or rely on local and / or regional PV vendors
Support PV vendor compliance oversight and issue identification and management
Support partner relationships and issue management in consultation with in scope LOCs
Serve as regional vendor governance coordinator and where appropriate governance lead for regional partner governance body / ies, where appropriate
Contribute to the validation of local and regional vendors list, including updates to the PSMF.
Develop and manage a balanced scorecard model that can be deployed as appropriate for regional vendor partnerships
Monitor vendor s results, identify trends and proactively collaborate to facilitate resolution, mitigate risks and ensure business continuity.
Develop reports for GPSE, as needed.
Ensure consistency across strategic regional partners
Support local and sub-regional PV vendor needs identification and selection process
Support development of local vendor oversight plans and associated actions
Support Snr Director, Regional Affiliate Relations & finance in LOC PV vendor budget forecasting and tracking activities to ensure a cost-efficient LOC PV vendor model
EDUCATION, EXPERIENCE AND SKILLS : (List the education and experience required to perform the primary responsibilities of the job.
Equivalent combinations of education and experience should be noted).
Excellent written / verbal communication skills and fluent in written and spoken English
Scientific and / or health professional (nursing etc) degree; bachelor’s required. Advanced degree preferred.
Min 3 years pharmaceutical or health care related industry experience required
Experienced in PV related environments, preferably at local, regional and / or global levels
Experienced in setup and maintenance of vendor relationships and establishing vendor oversight at a local, regional and / or global level
Experience of working cross-functionally. Experience working with or in a Pharma Commercial are preferred
Strong knowledge of PV regulations for the post marketing global environment and regional legislation in particular
Accuracy and attention to detail
High degree of cross-cultural awareness
Self-motivated and accountable team worker with collaborative approach. Experience working within virtual teams.
Ability to prioritise under pressure with well-developed organizational skills
High standard of computer literacy
Job ID R0016594