• Ensuring adherence to training plan along with appropriate work distribution amongst tagged team leads (n=6) and team members (n=120-150). After merging of teams from 4 different locations, managed 200-250 team members with 9 leads.• Managing aggregate safety report team for scheduling and reviewing safety reports. Ensuring timely submission and problem solving.• Setting up appraisal goals and performing appraisals with regular feedbacks.• Resolving people issues; resource issue… Show more • Ensuring adherence to training plan along with appropriate work distribution amongst tagged team leads (n=6) and team members (n=120-150). After merging of teams from 4 different locations, managed 200-250 team members with 9 leads.• Managing aggregate safety report team for scheduling and reviewing safety reports. Ensuring timely submission and problem solving.• Setting up appraisal goals and performing appraisals with regular feedbacks.• Resolving people issues; resource issue, intimation to supervisor about resignation/absconder and thereby controlling attrition, identifying and managing bottom performers.Process management tasks• Tracking and ensuring site level activities: production, quality, absenteeism and availability (considering work from home work style)• Ensuring SLAs and KPIs for the project are maintained as per contract, audit readiness• RCA CAPA management• Quality management • Follow-up metrics management for project, site level SLAs which included Prioritization, Regulatory/Licensee partner submission compliance, quality metrics.• Project ramp-up/ramp-down/spin-off experience o Increased site head-count from 50 to 150 during initial period, which included proper candidature selection, grooming, and ensuring limited attrition alongside of metric managemento Spin-off- retraining and ensuring no impact in process due to process change by implementing change management amongst all levels.o Ramp-down- adherence to changing project specifications and requirements keeping associate and leads interest intact. Closure and merger of 4 sites into 1 site and leading the change. Managing release and proper allocation of released candidates as per requirement Awards & Achievements:• Cognizant’s global associate recognition program: o Quarterly Bronze award (2022) for creating conditions for everyone to thrive.o Quarterly Silver award (2023) for managing the change and ensuring smooth run of operation during transition phase of the process. Show less

Generating/scheduling line listings for the aggregate reports from safety database and reviewing aggregate safety reports- PBRERs and PADERs to ensure data consistency cases (as per period) in the aggregate report and correcting the error if any, in the ICSRs with the help of respective teams.• Timely communication with the affiliates and various stakeholders to ensure correct, accurate data retrieval and submission to regulatory authorities. • Identifying and providing timely… Show more Generating/scheduling line listings for the aggregate reports from safety database and reviewing aggregate safety reports- PBRERs and PADERs to ensure data consistency cases (as per period) in the aggregate report and correcting the error if any, in the ICSRs with the help of respective teams.• Timely communication with the affiliates and various stakeholders to ensure correct, accurate data retrieval and submission to regulatory authorities. • Identifying and providing timely resolution to any foreseen or existing challenges in the process.• Evaluation from inwarding signal evaluation activities from various sources that includes safety database, FAERS, and Eudravigilance• Signal detection activities included literature evaluation and cumulative evaluation of products annual and biannual basis. Show less

• Coordinate between onsite and offshore teams• Managing project level deliverable • KPI measurement and to ensure project objectives are met as per SLA.• External/Internal customer engagement through continuous communication• Reconciliation activities with affiliates and license partners.• Managing teams functional in complete case management, error analysis and prevention, RCA/CAPA management• Preparation of training plan, work instructions, and training materials… Show more • Coordinate between onsite and offshore teams• Managing project level deliverable • KPI measurement and to ensure project objectives are met as per SLA.• External/Internal customer engagement through continuous communication• Reconciliation activities with affiliates and license partners.• Managing teams functional in complete case management, error analysis and prevention, RCA/CAPA management• Preparation of training plan, work instructions, and training materials. Imparting these trainings to project on all aspects• Daily workflow management and work allocation.• Established open and professional relationships with health care professionals, which helped, resolve issues and conflicts quickly.• Handling appraisals for project team• Shortlisting and interviewing candidates as per role requirements• Experience in internal/external Audits.• Reporting and Distribution verification of ICSRS Via gateway.• Generating/scheduling line listings for the aggregate reports from safety database and reviewing aggregate safety reports- PBRERs and PADERs to ensure data consistency cases (as per period) in the aggregate report and correcting the error if any, in the ICSRs with the help of respective teams.• Timely communication with the affiliates and various stakeholders to ensure correct, accurate data retrieval and submission to regulatory authorities. • Identifying and providing timely resolution to any foreseen or existing challenges in the process.• Evaluation from inwarding signal evaluation activities from various sources that includes safety database, FAERS, and Eudravigilance• Signal detection activities included literature evaluation and cumulative evaluation of products annual and biannual basis. Show less

Role: Trainer/MentorGuiding and mentoring new associates on Drug safety activities relating to ICSR processing (mainly Literature cases) as defined in Pharmacovigilance Scientist Level I job Description• Assigning case for processing to associates in mentoring phase• Resolving queries, identifying areas of concern, ensuring that outstanding training needs are addressed and timely feedback is provided for associates in mentoring• Assisting Client in the development and… Show more Role: Trainer/MentorGuiding and mentoring new associates on Drug safety activities relating to ICSR processing (mainly Literature cases) as defined in Pharmacovigilance Scientist Level I job Description• Assigning case for processing to associates in mentoring phase• Resolving queries, identifying areas of concern, ensuring that outstanding training needs are addressed and timely feedback is provided for associates in mentoring• Assisting Client in the development and implementation of training material and other associated documents.• Assisting in relevant Drug Safety projects and taking ownership for assigned processes and projects (as needed).Role: Literature team member• Accountable for reviewing and assessing validity of literature abstracts and articles with further processing onto the safety database as required• Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management. Show less

Industry: Medico-Sales Marketing (Neuroscience)Key Responsibilities:To identify and establish relationships with key opinion leaders (Doctors)/organizations in Neuroscience by understanding their needs and offering appropriate assistance in medical education programs, clinical/educational grants and knowledge building/enriching.To participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, customer… Show more Industry: Medico-Sales Marketing (Neuroscience)Key Responsibilities:To identify and establish relationships with key opinion leaders (Doctors)/organizations in Neuroscience by understanding their needs and offering appropriate assistance in medical education programs, clinical/educational grants and knowledge building/enriching.To participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc.To facilitate Medical /Marketing/Sales Force access to Specialists like Neurologists, Neurosurgeons, and Psychiatrists etc.To improve perception, Brand equity, Image & experience of doctors about the products in Neurosciences division. (i.e. being accountable for sales)To provide scientific and medical support to institutional sales initiatives. Show less

Industry: PharmacovigilanceKey Responsibilities:Management of Clinical Research Safety Data - PharmacovigilanceComplete Analysis of Adverse Events with respect to Causality.Scientific assessment of whole CaseDetection and reporting of suspected ADRs and other drug-related problems.Preparation of patient safety report for reporting to health regulatoryAwards & Achievements:Received "PAT-ON-BACK"- a token of appreciation from Drug Safety Department-… Show more Industry: PharmacovigilanceKey Responsibilities:Management of Clinical Research Safety Data - PharmacovigilanceComplete Analysis of Adverse Events with respect to Causality.Scientific assessment of whole CaseDetection and reporting of suspected ADRs and other drug-related problems.Preparation of patient safety report for reporting to health regulatoryAwards & Achievements:Received "PAT-ON-BACK"- a token of appreciation from Drug Safety Department- TCS.Received Appreciations from Client (Roche Pharmaceutical Ltd.) and TCS.Was single point of contact for 'E-Receipt Cases' Project in TCS. Show less