Pharmacovigilance

Associate Manager

• Handling all the lead activities for the assigned project 
• Responsible for prioritization of cases, ensure daily reconciliation activities and daily work flow management.
• Prioritization of cases as per the SLAs and ensure timely completion of ICSRs without impacting internal and external SLAs.
• Involving in investigation of late regulatory cases for the root cause of the delay and share it with the clients.
• Managing any client escalations and planning a mitigation activity for the same
• Designated to single point of contact for any queries pertaining to the case processing. Resolve the queries by referring SOPs, work instructions etc. and escalate it to the client whenever their invention is required.
• Responsible for managing and maintenance of all important process updates, training documents, attendance sheets and minutes of meeting.
• Performance monitoring of team along with Track day to day activities of team.
• Identifying problems and creating action plans to achieve desire quality and productivity on monthly basis.
• Responsible for preparing RCA and CAPA for the assigned project.
• Process improvement initiatives
• Sharing team stack report to the associates and higher management on monthly. 
• Identify training need for bottom performer and create action plan to achieve desire quality at individual and team level.
• Capacity planning monthly for the assigned team for smooth running of the engagement.
• Keeping attrition numbers low as possible as a part of attrition management.

Case processing and ICSR management 

• Expertise in processing and reviewing of spontaneous and PMS cases.
• Processed all types of special case scenarios like pregnancy, overdose, medication error, product      quality complaints, interaction, lack of efficacy etc 
• To enter the ICSR details i.e. patient information, adverse event information, drug information, lab test and reporter information into the drug safety database ARISg.  
• To write case narrative and present the details of the case.
• To code the adverse events on MedDRA dictionary.  
• To solve cases related queries of other as a subject matter expert (SME). 
• Quality review of ICSR. 
• To identify valid and invalid cases and cases eligible for expedite reporting (case triage). 
• Duplicate search and registration/book-in of ICSR.  
• Follow-up and query of spontaneous and PMS.