Monitor product safety remotely using adverse event analysis and signal detection for a globally recognized biopharmaceutical company. Work autonomously while communicating proactively.
This senior pharmacovigilance role supports continuous safety monitoring and regulatory reporting. You will assess adverse events, prepare safety documents, and contribute to risk management strategies. Collaboration spans clinical operations, medical affairs, regulatory affairs, authorities, and external partners globally.
Key Responsibilities:
Oversee adverse event collection, processing, and reporting
Conduct medical and scientific causality assessments
Detect safety signals and support risk management strategies
Prepare PSURs, PBRERs, and regulatory safety documents
Ensure FDA,
EMA, ICH, and SOP compliance
Requirements:
Degree in pharmacy, medicine, nursing, or life sciences
Minimum six years pharmacovigilance or drug safety experience
Knowledge of global regulations and reporting requirements
Experience with case processing, medical assessment, and signal detection
Proficiency in safety databases and office software
Apply senior pharmacovigilance expertise, analytical judgment, and regulatory knowledge to protect patients through global safety surveillance.
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