Drug Safety Consultant

Drug safety expert with special skills in

Drug safety & pharmacovigilance

Clinical development (CTPs, CDPs) and clinical safety (SCS, ICSR)

Negotiation of clinical phasestrategy and execution

Establishing a pharmacovigilance infrastructure for biosimilar products within the framework of the companies Pharmacovigilance System using an in- house case processing workflow for spontaneous reports

Creating and maintaining a tailored pharmacovigilance quality system

Clinical safety oversight over development candidates responsible for the safety section of Clinical Trial Protocols (CTP), Clinical Study Reports (CSR) and accountable for clinical safety in Marketing Authorization Applications (MAA) including Risk Management Plans (RMP) and Biological Licensing Applications (BLA)

Accountable for the Summaries of Clinical Safety (SCS) and safety content of the Clinical Overviews (CO), responding to regulatory assessor questions etc.

Accountable for in-market pharmacovigilance (PV) including individual case safety report (ICSR) processing and submission, signal detection and evaluation, compilation of aggregate reports, safety communication etc. for approved biosimilar products

Accountable for safety data exchange agreements (SDEA), and inspection performance (FDA BIMO inspection and BfArM/PEI PV inspections)

Concept Sheet Review Committee (CSRC) providing medical and methodological guidance to clinical development teams

Principle assessor to the Global Safety and Ethics Committee (GSEC) charged with the oversight over first in man (FIM)

Transitions and potential safety concerns arising during clinical development (e.g., clinical hold, additional risk minimization measures)

Establishing a dedicated clinical safety group supported by the case processing infrastructure of the company

Defining the safety strategy for the biosimilar’s unit

Clinical safety oversight for the biosimilar development candidates