Pharmacovigilance Specialist

Pharmacovigilance Specialist focuses on triage, intake, case entry and qc of icsrs originating from biogen sponsored studies or other assigned cases.

What the role involves

• Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases.
• Narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders.
• Perform retrospective quality checks on processed cases.
• Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time.
• Ensure case completion allowing for on-time regulatory reporting.
• Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management.

Skills and requirements

• Bachelor’s degree in science or healthcare related field.
• 4+ years expeirence in pharmacovigilance.
• Knowledge of Global and local safety regulations.
• Excellent written and verbal communication skills.

Confirmed role details

• $50-60/hr depending on experience.
• If you require reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.