Monitor and document all adverse events (AEs) and serious adverse events (SAEs) in accordance with study protocol, sponsor requirements, and applicable regulations.
Ensure timely and accurate reporting of SAEs to the Ethics Committee, Sponsor, and Regulatory Authorities as required.
Assist clinical staff in the identification, documentation, and classification of safety events.
Maintain up-to-date safety tracking logs and ensure proper storage of safety documentation.
Participate in safety review meetings and contribute to the preparation of safety summaries and reports.
Liaise with investigators, data managers, and monitors to reconcile discrepancies related to safety data.
Assist with training site staff on AE/SAE reporting procedures and safety protocols.
Support pharmacovigilance and risk management activities, as applicable.
Contribute to the development and maintenance of the Safety Management Plan (SMP).
Stay updated on evolving safety regulations and ensure compliance at all levels.

Qualifications:

Bachelor s degree in Pharmacy, Life Sciences, Public Health, or a related field.
Minimum 1 2 years of experience in clinical research safety monitoring.
Familiarity with Good Clinical Practice (GCP), ICH guidelines, and local regulatory reporting requirements.
Experience with safety databases and electronic data capture (EDC) systems is an asset.
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Ability to work collaboratively in a multidisciplinary team and across multiple sites

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