Nisha B. Email and Phone Number

Conduct workshops on LSMV. Set up customer calls, collect requirements from customer and update Configuration specifications (CS) document for customisation. Update Configuration templates for NLP extraction. Rapid implementation template update from ARGUS CBD and implementation. Support in database migration from Argus and ArisG to LSMV. Actioning tickets in JIRA for issues raised by customer and providing solutions. Resolution of queries.  Business analysis skillsWork very closely with Client and Software Product Unit management to define strategy for Pharmacovigilance & Safety solution.· Identify the new features to ensure that products have highest value functions many of which are differentiators against competition· Support Sales to in product positioning through superior value proposition and enhances consultative selling efforts· Final reference point on any functionality related clarifications· Steer the roadmap discussions during Product Steering Committee meetings and get the approval· Create and update the Configuration Specification (CS) Documents as per client config requirement· Provide the Business scenarios for end to end testing of the solution· Support in reviewing the best pharmacovigilance practices document·Understand the regulations and keeps update date with the regulations· Support Customer Working Group initiatives whenever needed

Project lead for clinical trial projects handling projects along with Safety Management Plan, Standard Operating Procedures, Work Practice, Guidance Documents authoring and reviewing. Post market SOPs, GD and WP.Trainer at MMS academy.Have received peer recognitions at global platform within the firm

Training staff for teaching the aspects of pharmacovigilance to aspirants who want to explore opportunities in pharmacovogilance

pharmacovigilance and project trainer, End of line quality reviewer, Quality and compliance management

Check for accuracy of data entry including coding of events using MedDRA and products using WHODD. Check for correctness and completeness of narrative in chronological order.Assume responsibility for quality of cases processed. Coordinating with medical reviewers when required. Followup queries where necessary. Performing overall quality check for the ICSR based on metrics and KPI for the team. Preparation and update quality metrics for ICSR and publish a quality report for the team on timely basis.Audit and compliance:Ensure compliance of operations with governing regulatory requirements for ICSRs.Trainings and compliance to be adhered.Preparation and audit readiness for internal and external inspections. Preparation of CAPA for audits and assure the appropriate closure within the agreed timeframe.Preparation of PADERS

I worked as an operations specialist and took up various job roles as a part of my designation. Including quality reviewe/assurance and training. I was SME for Argus and legal case processing. Trained the associates for a new project acquired by the company.Achievements:Received “Team Champ Award” in AUG-2016 for my contribution to stabilize the team.Received “Applause Award” in JUL-2016 for Best caption for SME (Subject Matter Expert).Received “Applause Award” in MAY-2016 for customer service. As I played a crucial role in success of the project.Received “Applause Award” for exceptional performance on 15-JAN-2016. As my contribution had helped the team to report all PVA due cases.

Worked as both Seriousness check Officer and Drug Safety Analyst, Screening Associate, Drug Safety Associate.Achievements:Won “Numero Uno Award” twice for high performance.Implemented an idea on “Standard query generation template”.

Teaching aspects and Practice of pharmacy for Bachelor's and Masters students.