Posted to MedZilla on 9/21/2017


ProClinical

Switzerland, Senior Manager/Associate Director PVG Case Management Operations DS_JS_13545-MZ


 
 

ProClinical is working with a global biopharmaceutical company that is leading the way in medical innovation to help patients live longer, better lives. Their purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. This biopharma are seeking a Senior Manager/Associate Director Pharmacovigilance Case Management Operations on a permanent basis to be based in Boudry, Switzerland.

Job Responsibilities:

  • Provide leadership and support for UK based Case Management Team
  • Ensure effective co-ordination of AE flow through the case management workflow in coordination with Swiss based team
  • Ensure process conformity with applicable regulations and company standards and ICSR conventions
  • Establishment, maintenance and monitoring of key performance indicators (KPI)
  • Drive Case Management process enhancement and team development
  • Case Management Operations Performance, Metrics & Resourcing
  • Lead goal setting, Key Performance Indicators (KPIs) development and performance management within the GDSRM International Case Management Operations team
  • Support central and where applicable affiliate resource calculation and contribute resourcing strategies including hiring and supervision of temporary contract staff
  • Liaison with HR Business Partners service providers including resourcing for temporary staff
  • Establish team metrics to support resourcing and contribute to the development of resource calculation tools
  • Responsible for the definition and generation of metrics addressing work volumes, compliance, quality and productivity
  • Manage the root cause analysis of issues revealed by review of metrics
  • Responsible for the determination of actions stemming from metrics review
  • Ensure team conformance with internal and external AE timelines
  • Oversee the daily flow of cases through Aris WF operating system.
  • Resolution of case prioritization issues
  • Co-ordinate workload balancing issues
  • Provide input to the resolution of issues relating to case complexity
  • Manage flow of cases outside of standard workflow as needed
  • Participate in notifying AE Management of department resources who fail to adhere to workflow business rules
  • Manage corrective actions stemming from internal or external AE case reports review
  • Oversee AE case report inquiries received from AE management team and LDSOs
  • Oversee AE case report inquiries received from NCA and other company stakeholders
  • Coordinate case assignment and completion to meet data lock points.
  • Coordinate the management of ICSRs received as a batch

Skills and Requirements:

  • Provide leadership and support for UK based Case Management Team
  • Ensure effective co-ordination of AE flow through the case management workflow in coordination with Swiss based team
  • Ensure process conformity with applicable regulations and company standards and ICSR conventions
  • Establishment, maintenance and monitoring of key performance indicators (KPI)
  • Drive Case Management process enhancement and team development
  • Minimum of B.Sc. or the equivalent combination of relevant education or professional experience
  • Eight (8) years pharmaceutical/biotechnology industry experience
  • Six years (6) Drug Safety experience
  • Excellent knowledge of pharmacovigilance regulatory requirements (Safety and Risk management i.e. FDA, EMA and ICH guidelines)
  • Ability to influence senior leaders in the company business without authority
  • Clinical knowledge of therapeutic area patient populations and drug class: oncology and I&I experience preferred
  • Proficiency in technical safety systems including ARISg and medical coding
  • Knowledge of aggregate safety data utilization
  • Good project management skills
  • Team leadership, people management and development/empowerment
  • Inspires and motivates
  • Fosters team work
  • Excellent influencing and leadership skills
  • Excellent written and verbal communication skills including presentation skills
  • Excellent interpersonal skills
  • Ability to identify and communicate issues within department and across geographies: Matrix management
  • Ability to resolve conflict
  • Stakeholder advocacy; promote open communication and build external relationships
  • Applies profound technical expertise
  • Effective Organisation and planning; ability to multitask and prioritize
  • Strong attention to detail, team work and initiative
  • Solution oriented with a global mindset
  • Strong analytical skills
  • Fosters a culture of Curiosity and Continuous Learning

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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