Drug Safety Associate II
Parexel International Corporation
Mohali, Punjab, India
Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc. • Perform literature searches as per search strategy, performs data entry of valid cases into the safety database • Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations • Responsible for sending translation requests, if any • Perform a check on overall medical cohesiveness and consistency of the document • Compares and analyses data provided by the affiliate with the data available on client application • Prepares ADR form/coversheet as required • Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool • Creates the case on the safety database • Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs) • Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events • Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider” • Request follow-up and perform query management, as applicable • Prepares medically cohesive case narratives based upon the reported information • Routes the case to the next workflow state as applicable in the safety database • Performs quality checks/validation checks • Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable • Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
QualificationsDegree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/ physiotherapy/ Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
Minimum 3 years of experience in ICSR processing