Aditi B, Rph Email & Phone Number

Ahmedabad, Gujarat, India

Overall oversight of MI project, manage scope and agreements of project and one point of accountability.Better customer engagement and management, manage escalations and internal stakeholder management.Lead establishment of all aspects of new program setup and launch, as needed. Resourcing and hiring as per project requirements (as applicable).Preparation, review and update of technical agreements related to Medical Information, if required.Participate in audits and regulatory inspections in cooperation with QA, as needed.Set up yearly objectives and review performances of team ensuring best use of available resources.Maintenance of various trackers for KPI, compliance and quality monitoring.

New Delhi, Delhi, India

• Monitoring and tracking of all open cases and triaging them effectively till closure • Maintenance of Quality & Productivity Trackers • Performs call reviews and provide constructive feedback to call handlers and the team• Review of weekly/monthly reconciliation reports. • Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders. • Execution of Company Standard Operating Procedures• Maintain awareness of changes to/new regulations affecting MI activities. • Trains and mentors new employees • To perform call reviews as per the process defined in APCER SOPs and provide feedback to the call handlers. • Provide ongoing assessment, feedback and review to the team for targets, call monitoring, and written communications. • Design and conduct training for the Medical Information team on SOPs and adverse event and product quality complaint reporting. • Ensure adherence to regulatory, legal, and pharmacovigilance requirements for MI. Perform periodic quality audits, in addition to ad-hoc checks.• Identifying gaps, developing process framework, suggest business improvement opportunities and re-engineering the process. Identify & drive opportunities to enhance Customer Experience • Assist team members to responds to inquiries and complaints received from HCPs, pharmacies, distributors, consumers and sales representatives; investigates / documents the questions & answers on the appropriate forms/database. • Process Excellence: Continuous and ongoing improvement plans within the process and team, identifying opportunities and develop plans for process improvement and excellence.

New Delhi Area, India

• To cater, manage, monitor client specific needs related to Medical Information deliverables• Quality Review of inquiries and complaints received from physicians, pharmacies, consumers and sales representatives; investigates / documents the questions & answers on the appropriate forms/database• Performs thorough medical literature searches in various databases (e.g. OVID, PubMed, EMBASE) • Contacts internal resources or clients to solicit information required for high level detail in order to provide accurate answers to product-related inquiries• Supports the creation and review of SOPs and other procedural documents• Monitoring and tracking of all open cases and triaging them effectively till closure• Maintenance of Quality & Productivity Trackers• Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders.• Prepares and Reviews Weekly/Monthly Reconciliation Reports.• Execution of Company Standard Operating Procedures• Maintain awareness of changes to/new regulations affecting MI activities. • Train and mentor new employees in MI (if required)• Medical writing deliverable with 100% accuracy

New Delhi Area, India

• Responds to inquiries and complaints received from physicians, pharmacies, consumers and sales representatives; investigates / documents the questions & answers on the appropriate forms/database• Supports Medical Information Department in updating and creating standard response letters and FAQs to ensure current and accurate information is being disseminated• Assumes responsibility to collect details of adverse events received by any medium (telephone, fax, email) and perform initial assessment according to local procedures and in accordance with drug safety procedures• Maintains and updates product information and other related documents in APCER or client-specific database• Performs thorough medical literature searches in various databases (e.g. OVID, PubMed, EMBASE) • Contacts internal resources or clients to solicit information required for high level detail in order to pro-vide accurate answers to product-related inquiries• Performs call reviews and provide constructive feedback to call handlers• Supports the creation and review of SOPs and other procedural documents• Mentoring new team members as and when required. Assisting the team members on real time on handling live calls and inquiries. • Assisting team members in sending client communications and notifications on real time• Prepares and Reviews Weekly/Monthly Reconciliation Reports.• Maintain awareness of changes to/new regulations affecting MI activities. • Complies with applicable ISMS related procedures & policies

Hyderabad Area, India

• Receive information on adverse events (Non-interventional studies), perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the tracking tool and/or safety database (Argus).• Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy. • Responsible for SAE processing, maintaining and tracking of ICSRs in order to maintain the regulatory compliance.• Use medical dictionaries (MedDRA) and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.• Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed.• Alert manager to potential safety signals based on incoming case reports.• Case corrections: Offline-QC of cases/corrections.

Hyderabad Area, India

• Receive information on adverse events (Non-interventional studies), perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the tracking tool and/or safety database (Argus).• Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy. • Responsible for SAE processing, maintaining and tracking of ICSRs in order to maintain the regulatory compliance.• Use medical dictionaries (MedDRA) and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.• Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed.• Alert manager to potential safety signals based on incoming case reports.• Case corrections: Offline-QC of cases/corrections.

Pune Area, India

• Description of Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation and submission to regulatory authorities.• Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search.• Assume responsibility for quality of data processed.• Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures/• Ensure compliance of operations with governing regulatory requirements.• Create, maintain and assume accountability for a culture of high customer service.

New Delhi, Delhi, India

• Involved in Collection, quality control, classification, medical review and reporting of case reports.• Understand and prepare safety reports and the entire case study of patient drug use and its side effects• Preparation and reviewing of Adverse Event Monitoring Forms as per seriousness and valid criteria.• Using of Argus Drug Safety Database for validation and up gradation of the existing consumer database.• Involved in creating Adverse Event Monitoring Forms, Product Quality Complain Forms and Medical Information queries as per seriousness criteria.• Involved in Case processing including review and assessment of SAE/AE reports (including narrative writing).

Greater Noida

• Receive case report from patients and HCPs in USA and documenting their experiences with the use of Pfizer products (prescription and OTC).• Filling up Adverse Event Monitoring (AEM) forms, including consumer narratives, for pharmacovigilance process of Pfizer.• Working on client software for entering and retrieving data.• Searching consumer information on ARGUS safety database.• To handle and close medical information requests and product quality complaints.• To check product complaints and provide appropriate responses.• To document cases and follow ups performed with consumers and healthcare professionals.• To create and check quality for AEM Forms on system and to make cases on PRIMA/ IRMS.

Bachelor Of Pharmacy (Verified By Wes Canada As Bachelors Degree), Pharmaceutical Sciences, First Division

Pgdm Executive, Operations Management, Pass