Sakshi Singh

Medical Reviewer Ii @PrimeVigilance

GB

For the Client:• To review and approve post-marketing Individual Case Safety Reports (lCSRs)and Serious Adverse Event (SAE) reports occurring in clinical trials formedical/causality assessment.• Review includes coding, assessment ofseriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.• To review literature screening search strategy• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings• Reviewing database outputs• To review and provide input in Periodic Safety Update Reports• To review and provide input in Development Safety Update Reports• Participating in signal detection activities including meetings and writing signaldetection reports• Evaluating and categorizing possible signals• Proposing a course of action whenever a possible signal is identifiedFor the Company:• Writing PV Procedures• Mentoring less experienced PhysiciansPhysician Line Manager• Distribution of tasks performed by physicians within designated team, as wellas solving problems related to it on a daily basis taking into account the quality of the work performed, respecting all relevant laws and procedures, as well as time limits• Ensuring stimulating work atmosphere within the team• Developing and maintaining good relationship with clients• Represent main contact person for responding to all medical questions from the client• Inform Medical Director about productivity and quality metrics of individual medics within medical team• Mentoring and coaching of staff within the team. • Develop team development strategy and monitor progress through quality and performance reports