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CAREER OPENINGS


Vendor Manager and Quality Monitoring

ID: 1628
Department: Drug Safety
Location: Cambridge Headquarters
# of Openings: 1

Description

GPS Vendor Manager & Quality Monitoring

Position Description:

In this key GPS role reporting to the Head of Global Patient Safety, the Manager is responsible for assisting the Head of GPS and team in monitoring and managing the Pharmacovigilance (PV) vendor to ensure delivery of work aligned with contractual obligations, agreed metrics, assuring the safety function is performing according to GxP and internal expectations and business needs.  The Manager is also responsible for leadership in pharmacovigilance quality and compliance for GPS. The scope will be managing the partner, monitoring and reporting internally the partners’ progress toward agreed goals and timelines as well as the vendors ‘compliance to GxP, and PV regulations The Manager will work in close collaboration with the Global Quality function on PV Compliance, including inspection and audit activities. He or she will track compliance, develop tools and metrics as necessary, ensure that deviations are adequately addressed and follow through corrective and preventative actions.  The role reports to Head of Global Patient Safety.

 

Responsibilities

  • Oversee compliance of PV Vendor in conduct of aligned key performance indicators of routine pharmacovigilance activities performed including, but not limited to: AE case processing, signal detection, global periodic reporting.
  • Facilitate PV outsourcing strategy conversation and decision-making processes within GPS and with partner(s)
  • Create processes related to assessment of PV vendor performance.
  • Develop business practices for PV outsourcing model(s), as appropriate.
  • Integrates PV best practices from other functions, as appropriate.
  • Development and implementation of PV business practices, policies and standard operating procedures (SOPs) to be used in GPS
  • Draft, review or support corrective and preventative action deliverables to ensure highest level of PV operational excellence and timely compliance.
  • Ensure PV Inspection Readiness in collaboration with vendor and other functions involved.
  • Ensure that GPS policies, guidelines, Standard Operating Procedures (SOPs) and Work Instructions (WIs) adequately cover a quality PV system internally and through applicable vendor(s) partner.
  • Reviews, documents, and escalates concerns and issues to PV management
  • Ensure an efficient, compliant PV systems structure with close interaction and oversight of vendor
  • Liaison expert between the vendors and GPS  group ensuring the production of best medical data outputs to perform the needed medical assessments. When needed, design and implement Innovative, efficient processes.
  • Monitor operational compliance, including agreed metrics of performance of company and partner/vendor for safety related activities, including database compliance
  • Responsible for internal GPS audits. Work with Global Quality and vendor on the Strategic/Tactical Audit and Inspection-readiness plans, including tracking systems and data retrieval plans
  • May interact with development partners on GPS quality and compliance activities such as common process documentation conventions and PSMF authoring and maintenance.
  • Maintain efficient communications with key stakeholders, including internal (Clinical Operations, Clinical Affairs, Regulatory Affairs, Global Quality Assurance) and external partners to share metrics, address compliance risks, and discuss new quality and compliance-related processes.
  • Act as subject matter expert in compliance management during audits and regulatory inspections.

 

Position Requirements

  • BS/MS degree in science or a health-related field; IT and/ or Project management degree a plus
  • At least 3 years of biotech/ pharmaceutical experience, including at least 2 years of experience in clinical safety/ PV and /or computer validation
  • Experience working with vendor/ partner desirable
  • Demonstrated knowledge of Drug Safety and Pharmacovigilance processes and operations systems with an understanding of interdependencies with other functions.  Broad knowledge of pharmaceutical compliance practices with ability to identify reasonable and fit-for-purpose approaches;
  • Expert knowledge of FDA, GVP, EU safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
  • Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization
  • Experience w MedDRA coding and safety databases systems (Argus)

 

Preferred Qualifications

  • Global pharmaceutical drug safety equivalent experience in combination with an advanced degree with less experience may be considered.
  • Safety reporting applications: knowledge of Oracle Argus Safety, clinical trial operations/electronic data capture and relationship with Drug Safety.
  • Experience with monitoring and managing progress on KPIs, Quality metrics and performance, internally and of a vendor.
  • Excellent written and oral communication skills. Strong presentation, facilitation, negotiation, collaboration and communication ability.
  • Demonstrated project leadership, follow-up, critical, tactical and innovative thinking, problem solving and analytical skills.  Team player; open minded, creative thinker.
  • Capable of working effectively under pressure in a multi-cultural environment, at any level of the organization, with a variety of stakeholders. 
  • Demonstrated effective project leadership skills


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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