Specific activities and responsibilities:

  • Routinely extracts and analyzes Safety and Vigilance (S&V) operational data from various sources to proactively monitor compliance and identify risk/areas for improvement.
  • Conducts monthly operational audit of identified activities per S&V Performance Improvement Plan, communicates findings to stakeholders in a timely manner and assists stakeholders with root cause analysis and development of corrective actions. Monitors effectiveness of corrective actions until steady state is achieved.
  • Mentors and assists operational staff to develop an understanding/application of pharmacovigilance quality principles for the writing of meaningful non-conformities prior to review by QPIs.
  • Supports other members of the assigned S&V project team(s) with the timely collection and analysis of performance data, including but not limited to the extraction of  monthly KPI data for assigned projects, trend analysis, root cause analysis and development of corrective actions. Monitors effectiveness of actions taken and communicates results in a timely manner to stakeholders.
  • Shares performance improvement findings from assigned projects with S&V BU management to ensure learnings are shared and applied across the BU.
  • Monitors specific S&V BU performance data, such as Procedural Review/Revision delivery compliance which are received from stakeholders outside of the S&V BU for delivery compliance/risk, communicates risk to S&V BU management, works with stakeholders to ensure timely resolution, monitors ongoing status until resolution, communicates status and collaborates with S&V BU management to achieve resolution.

 

Required education:

Life Science, healthcare or quality management degree

 

Minimum Required Experience :

  • Two years pharmacovigilance experience; case processing experience desired
  • Two years working in pharmacovigilance quality as it relates to PV operations

 

Required languages:

French + English (Native / Full Professional)

 

Required technical skills:

  • Understanding of pharmacovigilance principles and general global regulations with ability to apply principles to day-to-day situations, knowledge of available reference sources both internal and external to PLG, including global regulations
  • Ability to generate training materials and present trainings related to PV quality findings, and adjust training and concepts to level of recipient
  • Understanding of quality principles and applications, including PDCA (Plan-Do-Check-Act) as they pertain to pharmacovigilance delivery
  • Effective communication skills with the ability to adjust the style based upon the recipient’s needs.

 

Additional experience and/or skills:

  • Proficient in Word, Excel, Powerpoint
  • Ability to understand and generate compliance metrics and comparison data for analysis
  • Solid presentations skills with the ability to target a variety of audiences including staff, clients, management.
  • Ability to work independently and collaboratively within the S&V BU and across PLG BU’s as needed
  • Ability to apply critical thinking skills to thoroughly assess situations and develop/propose effective solutions

Safety & Vigilance Compliance Specialist (French Speaker) – VAF 281

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