Avinash Singh Email & Phone Number

Mysore, Karnataka, India

• Work closely with Client and Software Product Unit management to define strategy for Pharmacovigilance & Safety solution.• Provide functional expertise for new implementation, upgrade, configuration, data migration, report development and application support related tasks.• Participate in all System validation activities such as IQ/OQ/PQ/MQ for drug safety solutions and author the validation documents. • Provide functional leadership for internal and customer allocated project… Show more • Work closely with Client and Software Product Unit management to define strategy for Pharmacovigilance & Safety solution.• Provide functional expertise for new implementation, upgrade, configuration, data migration, report development and application support related tasks.• Participate in all System validation activities such as IQ/OQ/PQ/MQ for drug safety solutions and author the validation documents. • Provide functional leadership for internal and customer allocated project teams and hold responsibility for ensuring that project timelines are met.• Offer functional support in resolving application issues raised by customers. • Work closely with technical team and provide inputs during the time of application deployment to different clients across the globe.• Work closely with Project Managers in planning the project for the specified requirements.• 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. Show less

Pune, Maharashtra, India

 Oversee Drug safety monitoring team including QC review of cases and follow-up query management activities. Established and maintained effective project communications by representing my team at interdepartmental project/product team meetings, Partner/Vendor meetings and provide global collaboration. Manage relationships with Safety vendors, Business partners and function as the first point of escalation in case of issues and take appropriate action. SME on Pharmacovigilance… Show more  Oversee Drug safety monitoring team including QC review of cases and follow-up query management activities. Established and maintained effective project communications by representing my team at interdepartmental project/product team meetings, Partner/Vendor meetings and provide global collaboration. Manage relationships with Safety vendors, Business partners and function as the first point of escalation in case of issues and take appropriate action. SME on Pharmacovigilance ICSR Follow-up and Query Management activities. Contribute to a full range of Pharmacovigilance (PV) activities including cross functional operational activities, process improvement initiatives, quality systems, audits and inspections as required. Track status of assigned special projects and provide regular reports to senior management on status of projects and interactions with clients and maintained project materials. Provide comprehensive feedback for input into appraisals. Provide consistent and frequent feedback on quality, efficiency and development.  Support/train less experienced/new safety staff in all aspects of case-handling, adverse event reporting. Escalates issues with project deliverable, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner. Conduct training for new hires, assign training curriculum and prepare training/ workshop materials. Involved in mentoring co-employees and certifying the team/junior members in case processing and quality review. Apart from training new hires, is also involved in organizing & conducting several knowledge forums and training's on client SOPs, case processing and product specific conventions. Show less

Pune, Maharashtra, India

 Oversee Drug Safety Monitoring Team including QC review of cases and Follow-up Query Management Activities. Started Workflow Allocation and Process Improvement Initiatives Support/train less experienced/new safety staff in all aspects of case-handling, adverse event reporting. Assume the role of Subject Matter Expert (SME), participate & support in conducting several inspections and audits. Conduct training for new hires and prepare training/ workshop materials. Involved… Show more  Oversee Drug Safety Monitoring Team including QC review of cases and Follow-up Query Management Activities. Started Workflow Allocation and Process Improvement Initiatives Support/train less experienced/new safety staff in all aspects of case-handling, adverse event reporting. Assume the role of Subject Matter Expert (SME), participate & support in conducting several inspections and audits. Conduct training for new hires and prepare training/ workshop materials. Involved in mentoring co-employees and certifying the team/junior members in Case Processing and Follow-up Query Management Activities. Show less

Pune, Maharashtra, India

 Handled AE/SAE reports from multiple CT & PMS for submission to worldwide regulatory authorities according to applicable regulations and guidelines, standard operating procedures (SOPs), and Project requirements. Quality review of the ICSRs and providing the appropriate feedback to the associates. Generation of correction form as required according to the company SOPs, performing RCA and generating CAPA’s whenever required Perform Follow-up Query Management Activities.

Bengaluru, Karnataka, India

 Review, assess, triage, process, quality review and report the adverse event reports from spontaneous source and clinical trials according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.  Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for all ICSRs (Individual Case Safety reports) in order to determine whether there is an existing case file… Show more  Review, assess, triage, process, quality review and report the adverse event reports from spontaneous source and clinical trials according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.  Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for all ICSRs (Individual Case Safety reports) in order to determine whether there is an existing case file.  Creating a new electronic case report file or creating follow up files as necessary (case registry). Triage of incoming cases to determine seriousness and case validity.  Prioritizing the adverse event reports processing base on the ICH dates.  Confirming case registry data and complete remaining data entry, including relevant medical terminology, writing descripts narratives. Coding of medical history, reported adverse event terms and drugs in safety database using medical dictionaries like MedDRA, and WHO-DRL. Assessment of case reports for causality and expectedness. Filing PQCs (product quality complaints) associated with adverse events.  Performing quality review and checking cases for discrepancies for any errors by generating queries pertinent to the case. Setting up follow-up letter to the reporter for further case follow-up as per the applicable guidelines and reporting the case to the respective regulatory agencies.  Request for deletions /Admin edit as necessary. As mentor, training new team members on safety data processing and project related activities; and part of New Hire Orientation (NHO) Training /Mentor program in Pharmacovigilance Attend project team meetings and client calls related to the project and provide feedback to operations manager on any challenges/issues or successes.  Performing other case related activities (inconsistency checks, reconciliations etc) Perform other duties as assigned by manager. Show less

Bengaluru, Karnataka, India

 Performing case registry and triage of incoming cases to determine seriousness for prioritization of daily workflow Confirmation of previously entered data and completion of data entry, including coding adverse events, medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA, and WHO-DRL and writing adverse event case narrative. Filing PQCs (product quality complaints) associated with adverse events Follow procedures for… Show more  Performing case registry and triage of incoming cases to determine seriousness for prioritization of daily workflow Confirmation of previously entered data and completion of data entry, including coding adverse events, medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA, and WHO-DRL and writing adverse event case narrative. Filing PQCs (product quality complaints) associated with adverse events Follow procedures for supporting activities, such as requesting deletions, preparing deviation memos, etc. Show less

Master Of Pharmacy, Pharmaceutical Chemistry, 72.2% (First Class)

Bachelor Of Pharmacy - Bpharm, 67.4% (First Class)