Director Resource Strategy Oversight Sanofi Bridgewater

Job Description
This position is responsible for oversight and management on insourcing and outsourcing decisions for GPE Operations. As well as working with GPE Operations Leadership to develop and maintain workload forecasting, decision analysis and workload prioritization processes. This position will also be responsible for developing processes to document and track outsourcing activity for GPE Operations as well as comprehensive forecasts for use in developing operational strategies, resource allocation, budgeting and vendor budgeting purposes. This position will actively and dynamically make real-time resource allocation decisions in alignment with operational strategies.

Leadership, Teamwork and Management skills; Knowledge of International Regulatory requirements, thorough knowledge and experience in all aspects of Pharmacovigilance impacted by ICSRs, working knowledge of clinical medical practice and pathophysiology, working knowledge of computer systems and data processing.

Develop resourcing and work forecasting algorithms for key Operations deliverables, specifically but not limited to, ICSR case management and periodic reporting activities

Collaborate extensively with GPE Operational Leadership on the identification and
Quantification of workload and the development of decision trees to be used by leadership to
make informed decisions if internal or external resources are best for specific work

Develop and implement informative decision analysis tools to support workload forecasting of GPE deliverables, identification of resource needs and their allocation

Collaborate closely with GPE Business Management and Outsourcing to define and implement
GPE Operations Insource/Outsource Strategy

Develop and maintain documentation activities to ensure appropriate documentation exists
for GPE Operational resourcing decisions including the detailed documentation of outsourcing
decisions of specific components of workload.

Interface with other Pharmacovigilance Units including affiliate units to develop consistent
resourcing and workload procedures on a global scale.

Ensure “inspection-ready” documentation of resource allocation decisions and implementation

Regular

Minimum of 8-10 years Pharmacovigilance experience in PV Operations including ICSR case management and/or aggregate reporting.
Project and resource management experience needed as well.

Preferred

Experience with conduct of clinical trials; Experience in Affiliate (country)
Pharmacovigilance organization