Pharmacovigilance Specialist

Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.

Key Responsibilities:

• Triage, Intake, case entry and QC of ICSRs originating from *** sponsored studies or other assigned cases

• Includes 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 and 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

• Provide investigation details into late regulatory reporting of CT (Clinical Trials) cases

Essential Skills and Qualifications Required:

• Knowledge of Global and local safety regulations

• Excellent written and verbal communication skills

• Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva

• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance

• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)

• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required

Education and Experience Requirements for Job:

Education : Bachelor’s degree in science or healthcare related field

Experience : 4 years experience in pharmacovigilance

Applicants must be authorized to work for any employer in the US without sponsorship.