Kapil Sharma

• Assist Project Manager for project operation oversight.
• Provide oversight and direction of all Pharmacovigilance activities as Pharmacovigilance subject matter expert.
• Ensures delivery of high-quality Pharmacovigilance work by project team with compliance to agreed timelines.
• Proactively identifies, resolves/mitigates through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.
• Provide guidance to team and assist Project manager for any audit/inspection activities

My responsibilities:

• End to end processing of Human ICSR and triage, initiation and data entry of veterinary ICSRs
• Performing literature review of veterinary medicinal products
• MedDRA activities including MedDRA term mapping, Coding in i-medidata for SAE originating from ongoing clinical trails
• Quality review of ICSRs and MedDRA terms per client SOP
• Training and mentoring of new personnel
• Performing verification of data entered by new personnel for both human and veterinary ICSRs

My responsibilities:

• Processing of ICSRs of human origin from all sources (spontaneous, literature and clinical trials origin)
• Processing of ICSRs of veterinary origin
• End to end processing of human ICSR including triage, duplicate check, initiation, data entry, medical assessment and distribution
• Organizing workload to ensure compliance with regulatory timelines
• Maintaining good knowledge of safety profile of assigned drugs, client procedures and international drug safety regulations including ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, GVP modules, EU PV legislation related activities

My responsibilities:

• Overall Work Management of the Team
• Plan and deliver tasks and oversee a process/project within the agreed timescales.
• Develop and apply the relevant skills and knowledge to operate competently as a team leader and develop the skills within the team
• Daily workload management for staff and daily allocation of work
• Team motivation to achieve high team targets and KPI standards
• Handling client enquiries via E-mails and weekly meetings
• Resolving problems and issues which arise
• Mentoring and training up of juniors
• Implementing new initiatives
• Providing prompt and accurate information on individual performance