Life Sciences Staffing Specialists
Drug Safety

Makro’s offers a broad spectrum of Pre Clinical and Post Marketing consultants to the Pharmaceutical, Biotechnology and Medical Devices industries in:

  • Principles of drug safety evaluation
  • Classification of adverse reactions
  • Ensure timely reporting of adverse events to regulatory authorities
  • Monitor trends in frequency of adverse events to identify potential safety signals and inform appropriate Medical Officers
  • Providing Serious Adverse Events(SAE)/Expedited Adverse Events(EAE) reporting for numerous clinical trials
  • Providing Pharmacovigilance expertise to the management of patient risk management plans
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Developing the IND Safety and MedWatch Reports (Phases I-IV, Post-marketing drug safety surveillance)
  • Developing the study design, data collection and analysis plans, and prepares final reports summarizing study results
  • Conducting medical reviews of Individual Case Safety Reports (ICSR) for Serious Adverse Events (SAE), and Expedited Adverse Events (EAE)
  • Monitor trends in frequency of adverse events to identify potential safety signals
  • Monitoring drug safety in Clinical Research , identification and responding to drug safety hazards, actions to improve drug safety, post marketing, monitoring and decision making
Pharmacovigilance

Makro Scientific, with a focus on scientific, pharmacology, clinical development and post approval services is commited to providing experienced professionals to the pharmaceutical, Biotechnology, Medical Devices and CRO industries across the US

We have successfully recruited wide range of levels including Mid level Drug Safety Associates, Pharmacovigilance Scientists, Head of Drug Surveillance, Global PV Directors, and Medical information Associates/ Officers.

Our Core Areas of Clinical Recruitment: Pharmacovigilance

  • Head of Product Safety
  • Pharmacovigilance Compliance/ SOP Officer
  • Medical Advisor of Product Safety
  • Principal Pharmacovigilance Scientist
  • Senior Drug Safety Associate
  • Pharmacovigilance Systems Manager
  • Pharmacovigilance Scientist
  • Pharmacovigilance Administrator
  • Drug Safety Associate

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