Safety Physician (PR-34101533)

Ort: Bayern, Deutschland    |  Home office möglich
Gehalt: .
Spezialisierungen: Life Sciences
Vertragsart: Freelance
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++++ Freiberufler/Freiberuflerin Safety Physician gesucht ++++

Sie sind Experte/Expertin im Drug Safety Bereich, dann sind Sie der oder die Richtige!

Nutzen Sie die Chance und arbeiten Sie als Freiberufler/Freiberuflerin in einem innovativen Unternehmen.

Key Responsibilities

  • Analysis of comprehensive development and post market product information, synthesis, benefit-risk assessment and reporting, incl. RMP and aggregate report generation
  • Primary ownership and accountability for product signalling review, analysis, delivery and approval.
  • Proactive monitoring of product safety profiles from FIH throughout the lifecycle
  • Manages all medical safety aspects of allocated studies and post market products and serve as the subject matter expert from a medical safety perspective
  • Leadership and ownership of internal medical safety governance bodies including timely action and communication as per safety governance forums
  • PV audit and inspection preparation, support and lead in respect to product specific medical safety aspects
  • Provide medical safety oversight and key input to: protocols, investigator brochures, safety summaries, clinical study reports, regulatory reports (periodic, ad hoc) and labelling
  • Oversee and maintain PVA/SDEA management as well as CRO management in respect to medical safety processes
  • Ensure that all assigned medical safety activities are set-up in line with the PV standard operating procedures (SOPs) and relevant guidelines
  • Serving as main German QPPV and deputy EU QPPV as per qualification (optional)

Experience & Background

  • Medical degree - human medicine or veterinary medicine
  • 5 years of work experience in medical safety in a global position with marketed and development products (preferably phase 3 and beyond experience)
  • In depth knowledge of GVP, FDA guidance documents and in general global PV legislation
  • Safety database knowledge and data visualization skills
  • Fluent in German and English with strong written and oral skills
  • Effective communication and negotiation skills, comfortable with working in a matrix organization and able to break down problems to find solutions

Dauer: ca. 6 Monate

Auslastung: bis zu 40h/ Woche

Starttermin: Ab sofort

Remote Work

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