Sagar Thakare Email & Phone Number

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

◦ Ensures compliance with applicable Regulations or Standard Operating Procedures; specializes in drug safety management and medical supervision.◦ Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and avoiding adverse effects or side effects of marketed pharmaceutical products.◦ Responsible for important case report follow-up, searching adverse events, processing and… Show more ◦ Ensures compliance with applicable Regulations or Standard Operating Procedures; specializes in drug safety management and medical supervision.◦ Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and avoiding adverse effects or side effects of marketed pharmaceutical products.◦ Responsible for important case report follow-up, searching adverse events, processing and writing adverse event programs, serving link between the company, healthcare experts and patients for delivery of valid information on product safety.◦ Conducting and supervising regular pharmacovigilance processes; attending several product safety meetings and adding functionality to product safety.◦ Responding to General Patient Queries, Product complaints and maintenance of relevant information.◦ Handling of medical information inquiries, Identification, Compilation and Submission of Safety Variations impacting the product information and ensure timely implementation of the updated product information.◦ Perform and manage Literature Search activity.◦ Monthly reconciliation of adverse events with subsidiaries, partners and Pharmacovigilance service provider and verification on the availability of QPPV on an ongoing basis.◦ Any other function that may be required to fulfill regulatory requirement. Show less

Mumbai Area, India

Pharmacovigilance Department◦ Quality Review data from ICSRs from various sources (including EMA) on Argus Safety Database.◦ Responsible for handle and manage Safety Mailbox◦ Responsible for handle and manage Fax and Postal delivery.◦ Responsible for acknowledge and follow up of ICSR’s received from LRP ◦ Responsible for Classification and initiation of MI (Medical Inquiries) and PQC (Product Quality Complaint)◦ Perform data entry for tracking, coding relevant… Show more Pharmacovigilance Department◦ Quality Review data from ICSRs from various sources (including EMA) on Argus Safety Database.◦ Responsible for handle and manage Safety Mailbox◦ Responsible for handle and manage Fax and Postal delivery.◦ Responsible for acknowledge and follow up of ICSR’s received from LRP ◦ Responsible for Classification and initiation of MI (Medical Inquiries) and PQC (Product Quality Complaint)◦ Perform data entry for tracking, coding relevant medical terminology, writing descriptive narratives.◦ Generating queries pertinent to case and confirmations and thereby ensuring accuracy and consistency of acase against the source document and recording all relevant information in the database during assessment.◦ Proficient in Serious and non-serious adverse drug reactions case processing, Pregnancy cases and adverse events of special interest from various sources including spontaneous case reports and literature case reports.◦ Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (Spontaneous, solicitedprograms and Literature) which includes assessments like the assessment of seriousness, and companycausality for each adverse event, adhering to SOPs/other controlled documents and regulatory requirements.◦ Narrative writing according to the regulatory standards for ICSRs and timely completion of the assigned dataentry tasks for expedited reporting.◦ Handling reports of licensing partners and regulatory authorities.◦ Responsible for maintaining, tracking and reconciliation of case processing tracker. Show less

Mumbai Area, India

-Pharmacovigilance -Business Development Management◦ Client interaction and Business Development Management◦ Case management, allocation and comply with timeline (daily productivity) ICSR, PSUR and RMP.◦ Drafting/authoring of PSUR and RMP.◦ Triage, Booking and Case Processing (offsite and onsite).◦ Peer review of ICSR cases.◦ Evaluating Serious Causality expectedness assessment.◦ Database implementation, Team management and Training.◦ Mentoring new… Show more -Pharmacovigilance -Business Development Management◦ Client interaction and Business Development Management◦ Case management, allocation and comply with timeline (daily productivity) ICSR, PSUR and RMP.◦ Drafting/authoring of PSUR and RMP.◦ Triage, Booking and Case Processing (offsite and onsite).◦ Peer review of ICSR cases.◦ Evaluating Serious Causality expectedness assessment.◦ Database implementation, Team management and Training.◦ Mentoring new associates and maintains all the details required for out of QC certificate.◦ Attending client call for quality discussion and best practice session to ensure meeting quality standards for case processing.◦ Identification of valid case reports, triage and disposition of the valid reports in client database.◦ Trained for Clinical Data Management database (BizNET)◦ Website and brochures design for Clinical Research.◦ Site feasibility/Site selection and monitoring.◦ Evaluating Serious Causality expectedness assessment. Show less

Pune, Maharashtra, India

Clinical Records Management (eTMF)◦ Identification of clinical documents, including but not restricted to Study, Site, Country and Project Level.◦ Mapping of CREDI document types to Subway and Veeva Vault Artifacts.◦ Capture the attributes as per migration requirement based on content of document.◦ Meet the set production target as per agreed timelines.◦ Performing QC of documents processed by the Document specialist as per defined guidelines.◦ Making required… Show more Clinical Records Management (eTMF)◦ Identification of clinical documents, including but not restricted to Study, Site, Country and Project Level.◦ Mapping of CREDI document types to Subway and Veeva Vault Artifacts.◦ Capture the attributes as per migration requirement based on content of document.◦ Meet the set production target as per agreed timelines.◦ Performing QC of documents processed by the Document specialist as per defined guidelines.◦ Making required corrections/updating users to correct data as per feedback provided◦ Collation of all QCied data for final submission with all required checks◦ Conducting update sessions and error analysis session◦ Allocation to Team Members for production and resolving the query of team members.◦ Checking production sheets of team members, maintaining Quality logs Show less

Pimpri Chinchwad, Pune

Pune, Maharashtra, India

Master Of Business Administration - Mba, International Business

Bachelor Of Pharmacy (B.Pharmacy), Pharmacy

Activities and Societies: -Volleyball Player -Badminton Player

D. Pharmacy, Pharmacy, First Class