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Local Contact Person Pharmacovigilance (LCPPV) - Freelance - PT Poland

2 months, 2 weeks ago
Estonia, Latvia, Poland
Freelance
Junior
Compliance Manager
Operations
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Allucent

Allucent

Allucent is a full-service Clinical Research Organization that specializes in providing high-quality solutions tailored to the unique challenges faced by small to mid-sized biotech firms in the development and approval of new therapies.

Pharmaceuticals
1K-5K
Founded 1994
View All Jobs

Description

  • Act as the primary point of contact for local regulatory authorities, including 24/7 coverage where legally required.
  • Monitor and maintain awareness of local safety issues, regulatory recommendations, and pharmacovigilance legislation changes.
  • Support client audits and inspections, including document provision and completion of CAPAs when needed.
  • Perform local literature screening and collect safety information.
  • Assist with the development or review of the local pharmacovigilance system master file (LPSMF).
  • Support local signal detection and manage local risk minimization measures when applicable.
  • Report to and maintain regular communication with the EU QPPV.
  • Review local pharmacovigilance agreements when requested.
  • Deliver local pharmacovigilance training to sales teams, affiliate personnel, and distributors.
  • Provide monthly activity reports on the status of the local PV system.

Requirements

  • University degree, preferably in medicine, pharmacy, or life sciences.
  • Minimum 2 years of experience in post-marketing pharmacovigilance activities.
  • Up-to-date knowledge of applicable global and local regulatory requirements.
  • In-depth knowledge of the pharmacovigilance legal framework in the country where LCPPV services are delivered.
  • Fluency in written and spoken English.
  • Reside in the country where LCPPV services are delivered, if required.
  • Experience supporting pharmacovigilance audits, inspections, or CAPA activities is preferred.
  • Experience with local PV training, signal detection, or risk minimization measures is preferred.

Benefits

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental study/training budget for professional development.
  • Flexible working hours within reason.
  • Remote or office-based working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in the Buddy Program.
  • Internal growth opportunities and career progression.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Spot Bonus Award Program for going above and beyond.
  • Loyalty Award Program for longstanding employees.

Interested in this position?

Apply directly on the company website

Apply Now

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