Drug Safety Manager

The Senior Manager of Drug Safety supports drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies. Responsibilities include initial safety review of adverse events, medical review of clinical data, interaction with external drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities.

• Participate in the operational aspects of adverse event reporting for investigational products.
• Ensure consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy, and legibility.
• Ensure accurate MedDRA coding of adverse event terms, medical history, and WHO Drug coding of concomitant medications.
• Support the clinical research team in the preparation and review of safety reports and data (e.g., annual safety reports, cumulative SAE reports, safety database outputs, clinical study reports, regulatory safety reports, and tables/listings/figures).
• Participate in SAE reconciliation activities.
• Support timely safety review of adverse events to determine seriousness, expectedness, causality, and event resolution.
• Review serious adverse events and provide causality assessments in collaboration with medical monitors or drug safety physicians.
• Provide oversight of end-to-end case processing and reviews.
• Interact regularly with external vendors and internal departments (e.g., data management, medical affairs, biostatistics, clinical operations) to resolve safety-related issues.
• Review safety data outputs for accuracy and completeness prior to internal and external submission.
• Maintain current knowledge of applicable drug safety regulations and guidelines and apply them to safety activities.
• Assist in the preparation of safety documents for regulatory submissions in collaboration with regulatory affairs.
• Author and/or review clinical documents as applicable (e.g., protocols, study plans).
• Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures.
• Maintain knowledge of relevant disease areas and therapeutic indications for marketed and investigational products.
• Support medical affairs with adverse events related to marketed products.
• Perform additional pharmacovigilance-related tasks as required.
• Demonstrate experience with post-marketing pharmacovigilance activities.
• Author and/or review post-marketing safety reports (e.g., PSURs, PADERs, PBRERs).

Supervisory Responsibilities

• None

Knowledge & Other Qualifications

• Degree in a medical or life science field (e.g., RN, PharmD, MD preferred) or equivalent experience with an advanced degree.
• Minimum of 4 years of relevant drug safety or pharmacovigilance experience.
• Knowledge of medical and therapeutic terminology.
• Experience in medical monitoring and medical review.
• Experience authoring or reviewing Standard Operating Procedures.
• Experience working with safety databases.
• Working knowledge of ICH guidelines and global safety regulations.
• Demonstrated knowledge of regulatory requirements related to patient safety and adverse event reporting, including periodic reporting.
• Understanding of patient safety case-handling processes, including regulatory reporting requirements, policies, and procedures.

Other Characteristics

• Ability to work independently and collaboratively while maintaining high ethical standards.
• Innovative, proactive, and adaptable approach to work.
• Self-motivated with the ability to function effectively in a team environment.
• Willingness to perform additional duties as assigned by management.
• Authorization to work in the applicable country without sponsorship.