Pharmacovigilance Medical Lead
Our client is a biotechnology company. They have asked us to assist them in their search for a Pharmacovigilance Medical Lead.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides safety medical support for the Clinical Development portfolio.
- Provides medical review of clinical ICSRs and clinical study coding.
- Collaborates cross functionally on submission of safety documents and other required study reports.
- Provides company approval for external safety reporting to health authorities, investigators, and partners as required.
- Collaborates with global partnerships in complex combination product development.
- Contributes to relevant study related documents from a clinical safety perspective.
- Reviews and synthesizes clinical safety data with study team for committee members.
- A Medical degree is required with clinical medical experience preferred.
- Must have at least 10 years of pharmacovigilance experience in the pharmaceutical industry, including developmental product pharmacovigilance.
- Pre-clinical, Phase I to Ph III experience with a particular focus on Phase III (large scale global clinical trials) is required.
- Global PV experience required. Previous experience with developing countries and target populations is a plus.
- Experience in Infectious Diseases or Vaccines experience is a plus.
- Must have a detailed knowledge of GCP, ICH Guidelines and US FDA regulations.
- Requires experience working in a highly matrixed organization.
- Clear and effective communication and diplomacy skills are required.
- Must have excellent leadership and interpersonal skills and the ability to collaborate across disciplines.
- Requires approximately 20% local and international travel.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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