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

ProductLife Group; Courbevoie; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading pharmacovigilance firm in Courbevoie is looking for a professional to analyze operational data and ensure compliance within their teams. Responsibilities include conducting audits, mentoring staff, and generating training materials. Ideal candidates should have at least two years of pharmacovigilance experience and a degree in Life Science or healthcare. Proficiency in both French and English is required.

Qualifications

• Two years pharmacovigilance experience, case processing experience desired.
• Two years working in pharmacovigilance quality related to PV operations.
• French + English (Native / Full Professional)

Responsabilités

• Extracts and analyzes S&V operational data from various sources.
• Conducts monthly operational audits and communicates findings.
• Mentors operational staff on pharmacovigilance quality principles.

Connaissances

Understanding of pharmacovigilance principles

Effective communication skills

Critical thinking skills

Formation

Life Science, healthcare or quality management degree

Outils

Word

Excel

PowerPoint

Description du poste

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