Sr. Safety Associate

Reference: 631738

Posted:

Location:

Cambridge, MASalary: $50 - $60

Company:
Planet Pharma Group Contact:
Applications Email: applications

Pay Range: $50-60/hr

* depending on experience

Job Scope:
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 Biogen 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 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 :
Bachelors degree in science or healthcare related field
Experience : 4+ years experience in pharmacovigilance
(No Value)