07. 02. 2018

Pharmacovigilance Compliance Specialist

RegijaBeogradski region

Vrsta posla:Stručne i rukovodeće pozicije


Opis
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Our client is PharmaSwiss, a division of Valeant Pharmaceuticals International - an international pharmaceutical company offering full third-party representation of portfolios of several prestigious clients, and also marketing strong complementary portfolio of own pharmaceutical products. 
For their Global PV & Risk Management Department, Adecco is looking for motivated candidates for the position based in Belgrade.


Required qualifications:
  • University degree in Pharmacy or Medicine
  • Minimum 3 years of relevant work experience in PV
  • Fluency in English
  • PC literacy

Main responsibilities: 
  • Assist with preliminary audit/inspection preparation, and document/interviewee facilitation, document/repository management/oversight for GSE as needed
  • Assist with the development  and/or recommendation appropriate corrective actions related to audit/inspection findings
  • Assist with CAPA Management and tracking for PV Audits including follow up activity regarding audit/inspection commitments and responses to ensure documentation is adequate and timelines are met
  • Ensures   management is kept up to date with all inspections tracking responses and commitments 
  • Assist with the compliance of GPRM Quality Management System 
  • Supports updates to GPRM controlled documents and training requirements as needed
  • Assist in the development of  a strategic direction for CAPA activities that are aligned with   business and quality initiatives and in compliance with all regulatory requirements
  • Analyze trends to monitor the effectiveness of the CAPA process and  remediation for improvement
  • Assist  with departmental compliance of SOPs and process improvements
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes
  • Assist with the management of  Planned / Unplanned Deviation and CAPAs 
  • Review and analyze data and documentation
  • Participates in special projects and process development activities as assigned

Candidate’s profile:
  • Clear, effective written and verbal communication skills
  • Strong organizational skills and high attention to details
  • Ability to meet tight deadline
  • Ability to work well in a matrixed, global team environment
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Broj oglasa JN -022018-4145