Sunday, 17 November 2013

131361BR


Over The Counter
Over The Counter
USA
Parsippany, NJ
Novartis Consumer Health
Development & Medical
Full Time
Regular
Job Purpose:
Provide pharmacovigilance expertise to the multi-function, fast pace of DSP to ensure productive, efficient and compliant processes including but not limited to budget, building, documents and resources. ’Provide operational and logistical support to all functions of DSP. Lead DSP (centrally and locally) with regard to all exchange of safety information across business sectors internally and externally; including Pharmacovigilance Agreements (PVAs), Shared Product Agreements (SPAs), Service Level Agreements (SLAs) and Third Party Contracts.

Major Accountabilities:
•Define strategy and lead global implementation of the creation and maintenance of all agreements required to support the complaint exchange of pharmacovigilance data, which entails
oOngoing interaction with BD&L, Legal, QA, NCH Affiliates, other Novartis Sectors and other relevant parties
oOngoing interaction with NCH License Partners and Third Parties
oLeading strategic negotiations with all Counter-Parties to maintain compliance with all applicable regulatory requirements, maintain compliance with NCH SOPs and GGDs and ensure all contracts are negotiated with NCH’s best interests in mind
oLeading Cross-Sector Initiatives for Shared Products
oCreate, revise and maintain templates for PVAs, including those for divesting products
oDefining configuration requirements for the safety database to ensure all cases are reported in a compliant manner
oProviding training on all executed agreements to Central DSP, NCH Affiliates and other parties as needed
•Proactively identify business drivers and changes (e.g. global regulatory changes, new product launches), and incorporate into processes and plans to ensure improvement and efficiency gains


•Lead Global Vendor Management Activities for DSP, including
oLead negotiations as subject matter expert with vendors for best price as well as invoice disputes
o Creation and execution of RFPs, GSA/MSAs, Task Orders and all other relevant documents
oManage receipt of invoices and payments to vendors
oEnsure DSP outsourcing spend is accurate, updated and communicated to relevant parties
oDSP contact for Procurement/Sourcing, Finance, and Legal for all DSP-related financial con-tracts

•Manage all Logistics Activities for DSP, including
oDSP Representative for resource allocation
Participate in development and implementation of resource allocation tools
Train DSP and act as primary point-of-contact on resource allocation and related tools
oAdministratively manage the following DSP associates, located in PPY:
DSP & GRA Systems Group (4-6 employees)
Global Compliance Group (4-6 employees)
oFunctionally and administratively manage PPY Administrative staff (1-4 employees)
oOversee all aspects of DSP-related building services (e.g. seating, file room access)
oDefine document storage/management strategy for DSP; implement strategy and maintain capability
oMaintain content on DSP intranet website
oLead l Human Resources-related activities as specified below:
Create and/or maintain all DSP job requisitions, role profiles, and CVs
Calculate and track attrition rates
Develop and implement strategies for global DSP career ladders
Interact with other NCH line-units to identify integration points and define related processes and
responsibilities (e.g. Medical Affairs – IIS SOP)
•Define and drive implementation of CAPAs related to PVAs, SLAs, etc. in response to quality and compliance issues
•Participate in Health Authority inspections and internal audits as required



•Lead Budgeting Responsibilities for DSP, including
oDevelopment, implementation and maintenance of process to manage/track DSP Structure Budgets (Nyon & PPY)
oCreation and justification of Annual Structure Targets for DSP (Nyon & PPY), with approval from Global Head of DSP
oManagement of cross-charges from/to other Novartis Sectors
oLead and Manage Forecasting for DSP across all functions
oDSP contact for Finance
•Lead Global Operations & Logistics staff, including
Resource planning and recruiting
Training, development, and coaching
Work prioritization, resource allocation and delegation
Establish overall performance objectives for the group in line with department objectives; monitor progress of and quality of deliverables and take corrective action as necessary
•Issue resolution / escalation
Education :
Bachelors degree or equivalent required (degree in healthcare related or life science field preferred); Advanced degree preferred

Experience:
Required:
•Minimum 10 years of pharmaceutical or related industry experience
•Minimum 8 years in Drug Safety
•Minimum 4 years experience with agreements related to the exchange of safety data
•Minimum 4 years of operational logistics experience (e.g. budgets, sourcing, contract negotiation)
•Minimum 5 years of Management experience
Preferred:
•OTC experience
•Experience working in a global environment

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