Akanksha Sinha

Experience

• 

  Tata Consultancy Services

  Sept 2014 - Sept 2018

  Pharmacovigilance scientist 1

  • Accountable for handling ICSRs received via data exchange systems, disposition of valid items into ARIS from IRT for further processing in ARIS. • Accountable for performing accurate data capture for individual case safety reports which can be spontaneous, clinical and non interventional program• Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP• Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive work flow management• Identified and handled Suspected Unexpected Serious Adverse Reaction reports (SUSARs) for Investigational Medicinal Products (IMPs) and Comparators within 7 days and 15 days timeline.• Performing MedDRA coding assessment. • Assessing causality for safety cases reports. • Perform expectedness assessment and ICSR report ability. • Generate follow-up questions for the cases. • Respond to queries from clients as required. • Standard operative procedures and regulatory requirements. Show less

• 

  IQVIA

  Nov 2018 - now

  Operation specialist 1

  Individual case safety processing, case processing and narrative writing on Arisg.