Pharmacovigilance Case Processing Specialist

About the role

Seeking an experienced Pharmacovigilance professional to support the safety evaluation of commercialized and investigational pharmaceutical products. This role is responsible for adverse event case processing, safety data review, signal detection activities, regulatory reporting, and pharmacovigilance compliance.

Responsibilities

• Review, assess, and process adverse event (AE) and serious adverse event (SAE) reports from clinical and post-marketing sources.
• Evaluate case seriousness, expectedness, causality, and regulatory reportability.
• Enter and maintain accurate safety data within the pharmacovigilance database, including narrative development and quality review.
• Manage follow-up activities with investigators, healthcare providers, and other reporters to obtain complete safety information.
• Prepare and submit expedited safety reports to global regulatory authorities and relevant stakeholders within required timelines.
• Support signal detection, safety surveillance, and risk-benefit assessments.
• Generate safety data outputs, reports, reconciliations, and analyses for internal stakeholders.
• Respond to, or assist with, regulatory authority inquiries related to safety matters.
• Deliver pharmacovigilance training to internal and external stakeholders as needed.
• Reconcile clinical trial safety data with data management and other functional groups.
• Coordinate safety review meetings and support ongoing safety governance activities.
• Maintain compliance with global pharmacovigilance regulations, GVP requirements, and evolving industry standards.
• Support safety audits, inspections, and partner/vendor pharmacovigilance oversight activities.
• Assist with study start-up activities, including safety database configuration and safety reporting documentation.
• Contribute to business development and partnership activities by providing pharmacovigilance expertise.
• Support departmental process improvements, SOP development, and operational excellence initiatives.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required.
• Master's degree or PharmD preferred.
• Minimum 5+ years of pharmacovigilance/drug safety experience with a Bachelor's degree, or 3+ years with a Master's or PharmD.
• Experience using Argus Safety or comparable pharmacovigilance databases.
• Strong understanding of adverse event case processing, safety assessment, and signal detection.
• Experience preparing and contributing to periodic safety reports.
• Comprehensive knowledge of global pharmacovigilance regulations, GVP, and drug safety requirements.
• Familiarity with GCP and ICH guidelines.
• Excellent communication, training, and stakeholder management skills.