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Senior Drug Safety Manager (m/w/d)

  • Location: Frankfurt (Oder), 60306
  • Salary: €70000 - €120000 per annum per year
  • Job Type:Permanent

Posted 25 days ago

  • Sector: Pharmaceutical, Biotech
  • Contact: Patrick Roussos-Quandt
  • Contact Email: p.roussos@sciproglobal.de
  • Start Date: ASAP
  • : Takeda
  • Expiry Date: 12 August 2022
  • Job Ref: 2022_0722_1657698923

Senior Drug Safety Manager (m/w/x) | Frankfurt | Pharma

Our client is a global with an absolute interesting portfolio based on biologics. With almost 2000 workers globally our client covers pre-clinical and clinical development to production and worldwide marketing.

These products are specifically used to help people with serious and often chronic diseases to return to a normal life.

What will your tasks as Drug Safety Manager be?

  • Preparation and review of safety-relevant clinical studies Creation and revision of departmental and cross-interface work instructions and other quality management documents
  • Preparation of periodic safety reports (PSUR/ PBRER/DSUR), RMPs and signal management
  • Creation and review of safety-relevant clinical reports (DSUR, CSR), clinical expert statements and corresponding chapters in approval dossiers
  • 2nd line Medical information
  • Medical Review

Your requirements?

  • Medical Doctor
  • Minimum 4 years' experience in global / local Pharmacovigilance OR PV experience in a higher federal authority or scientific institution
  • Good knowledge of European and international regulatory requirement in the PV field
  • German: fluent in spoken and written, English: fluent

Is this role interesting for you and you want to know more about it?

Do not hesitate to contact me immediately.

I am looking forward to your call.

My contact details: