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Clinical Safety Expert

1 week ago

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Clinical Safety Expert Position:
We are seeking a highly experienced Clinical Safety Expert to join our team at ProductLife Group. In this role, you will lead medical review teams and provide expert advice on drug safety to our clients and their patients.

About Us:
At ProductLife Group, we are committed to delivering high-quality services that meet our clients' needs. Our team of experts is dedicated to ensuring that our clients' products are safe and effective for use by patients around the world.

Your Responsibilities:
As a Clinical Safety Expert, your key responsibilities will include:

  • Leading medical review teams to ensure compliance with regulatory requirements
  • Providing expert advice on drug safety to our clients and their patients
  • Developing and implementing medical monitoring plans (MMPs) to ensure patient safety
  • Reviewing adverse events (AEs) reported by study sites and determining appropriate actions
  • Assessing the severity of AEs and determining their reportability
  • Performing clinical data reviews and drafting monthly reports for our clients

Requirements:
To be successful as a Clinical Safety Expert, you will need to have:

  • A strong background in medicine, preferably with an MBBS or MD degree
  • At least 10 years of experience working in the pharmaceutical industry or as a service provider
  • Experience in leading medical review teams and client communications
  • Knowledge of GVP, GCP, FDA, and regulatory requirements related to drug safety
  • Strong understanding of pharmacovigilance principles and adverse event reporting

Why Join Us:
As a member of our team, you will enjoy a range of benefits, including:

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • A dynamic and supportive work environment