Performs safety case processing tasks including, but not limited to:• Intake tasks• Reviewing incoming safety information for completeness and accuracy• Ensure that all patient identifiers (PHI) in source documents (SD) have been completely redacted• Coordinate translation of source documents, if applicable and ensure reports are sent to the customer within assigned deadlines.• Tracking and data entry with coding of relevant medical terminology• Writing clinical narrative.• Generating queries• Contacting sites for missing and/or unclear information• Generating regulatory reports• ReconciliationPerforms other related duties as assigned or requested by Safety Management• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities.• To meet the requisite turnaround time for expedited reporting per client expectations with timely generation and submission of MedDEV reports on a weekly basis, as per country specific submissions.• Solid knowledge of clinical research process and medical terminology.

Provide necessary support for HPLC method development and validation.• Analytical method development and their validation (for precision, accuracy, selectivity or specificity, linearity & range limit of detection, limit of quantization, ruggedness)• Help design and execute trial runs to help qualify new analytical methods and optimize existing methods• Calibrate HPLC systems