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Drug Safety Operations Lead
1 week ago
About the Role:
We are looking for an experienced Drug Safety Operations Lead to join our client's team as a Pharmacovigilance Manager. This is a mid-senior level position, requiring a strong background in drug safety operations, pharmacovigilance, and project management.
Key Responsibilities:
- BSc in Pharmacology or similar relevant discipline. Postgraduate qualifications are desirable (e.g., MSc, PhD, PharmD, MD, or equivalent).
- Depth of experience in clinical trials and drug development processes, particularly in drug safety applications and regulatory compliance.
- Knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, and computer system validation guidelines.
- Experience in service delivery of drug safety projects and proficiency in ARGUS or equivalent drug safety database.
- Strong expertise in Microsoft Office and ability to work effectively in a hybrid environment.
What We Offer:
A competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.
