Senior Safety Physician oder Senior Safety Scientist (m/w/d) – freelance -closed

  • Position zu besetzen ab 1. Februar 2019
  • Permanent-ID OCR-FL-2019-1010 und OCR-FL-2019-1011
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben

Tätigkeit als Global Safety Physician (OCR-FL-2019-1010) oder Scientist (OCR-FL-2019-1011) mit Erfahrungen im Bereich Pharmakovigilanz

Anforderungen Global Safety Physician

Clinical experience as physician (approx. 3 years), specialization is a plus
Experience in international and Global Drug Safety Environment Post-marketing and Clinical settings > 5 yrs.
In-depth knowledge of signal-detection, risk management and benefit-risk management >3-5 yrs.
MD with clinical experience and pharmacovigilance settings >3-5 yrs.
Sound expertise in the field of Pharmacovigilance and the applicable current regulations: EU (Good Pharmacovigilance Practice (GVP); FDA (REMS, INDSR); ICH guidelines, MedDRA coding >3-5 yrs.

Anforderungen Global Safety Scientist

Professional experience in an international environment >3-5 yrs.
industry experience, preferably including both clinical development and pharmacovigilance experience including medical safety evaluation and safety based decision making >3-5 yrs.
English business fluent
Excellent knowledge of product development process and experience of cross-functional team work > 5 yrs.
First-hand experience in handling safety issues related to known target organ toxicities and good understanding of the therapeutic areas >3-5 yrs.
MD or Master of Science/Ph D with work experience in pharmacovigilance area >3-5 yrs.

Zusätzliche Informationen
Standort: Darmstadt & Remote
Projektbeginn: 01.02.2019
Projektlaufzeit: 29.02.2020
Verfügbarkeit: Vollzeit
On-site Support: 85 %
Remote Support: 15 %