Milind Mali

Experience

• 

  Cognizant

  Jul 2015 - May 2016

  Trainee Drug safety associate

  1. Coding: Convergent with MedDRA coding of Relevant Medical History, Indication, events and lab details. Coding of suspects and concomitants by using CDD and WHO DD.2. ICSR case processing: Assessing validity and seriousness, splitting, linking, Med-DRA, WHO DD and CDD coding, narrative writing, generating follow-up information, data entry of all type of cases.3. Triage: To determining the priority of patients' treatments based on the severity of their condition & prioritizing the case for reporting to authorities.5. Labelling: Convergent in labelling of the events as per the labelling documents. Other: End to end case processing in safety database starting from a data entry, selecting the adverse events, assessing dechallenge and rechallenge and writing descriptive narratives.6. Triaging of solicited/unsolicited cases of both serious and non-serious types along invalid literatures7. Data entry of reports of solicited, unsolicited cases into the client safety database (Argus 7.04.1)ICSR case processing (case to case processing including all type of cases) and writing case narratives8. Familiar with global safety databases like ARGUS, AWARE and Aris G Review and perform Quality check of serious adverse events (SAE’s) generated for post marketed cases9. Processing of litigation cases with accuracy and completeness Communicate daily with clinical investigation team and client in terms of queries to ensure accuracy of data for timely completion of tasks 10. Effective handling of client calls during implementation of project related updates from time to time. Show less

• 

  Cognizant

  Nov 2016 - May 2017

  Drug Safety Associate

  1. Coding: Convergent with MedDRA coding of Relevant Medical History, Indication, events and lab details. Coding of suspects and concomitants by using CDD and WHO DD.2. ICSR case processing: Assessing validity and seriousness, splitting, linking, Med-DRA, WHO DD and CDD coding, narrative writing, generating follow-up information, data entry of all type of cases.3. QR/QC: Involved in checking the consistency of case & valid information in database against the source document, query raising, quality check of FU received and send the same to MAH.4. Triage: To determining the priority of patients' treatments based on the severity of their condition & prioritizing the case for reporting to authorities.5. Labelling: Convergent in labelling of the events as per the labelling documents. Other: End to end case processing in safety database starting from a data entry, selecting the adverse events, assessing dechallenge and rechallenge and writing descriptive narratives.6. Triaging of solicited/unsolicited cases of both serious and non-serious types along invalid literatures7. Data entry of reports of solicited, unsolicited cases into the client safety database (Argus 7.04.1)ICSR case processing (case to case processing including all type of cases) and writing case narratives8. Familiar with global safety databases like ARGUS, AWARE and Aris G Review and perform Quality check of serious adverse events (SAE’s) generated for post marketed cases9. Processing of litigation cases with accuracy and completeness Communicate daily with clinical investigation team and client in terms of queries to ensure accuracy of data for timely completion of tasks 10. Effective handling of client calls during implementation of project related updates from time to time. Show less

• 

  APCER Life Sciences

  May 2017 - Mar 2020

  Case assignment1. Team handling and End to End ICSR Case processing2. Handing Huddle and Quality Reviewer3. RCA & CAPA Management4. Reconciliation on daily basis,5. Queries management and Pharmacoviglance Audits and inspections6. SOP management and record management7. Mentoring of new joiner and training management. 8. Act as Team leader. 9. ICSR reporting, processing and its management10. Reconciliations, Validations and Adjudications11. Audit, Client Call, Inspections and process improvements Show less *Perform registration of initial and follow up information for Solicited/ Unsolicited cases of both serious and non-serious types.*Triaging and data entry of reports into the client safety database. ICSR case processing (exposure to Clinical Trial cases, PMS cases, Drug PTC cases, Literature cases). Writing case narratives, Case to case processing Convergent with Global Safety Databases like ARGUS and AWARE.Roles:1. Coding: Convergent with MedDRA coding of Relevant Medical History, Indication, events and lab details. Coding of suspects and concomitants by using CDD and WHO DD.2. ICSR case processing: Assessing validity and seriousness, splitting, linking, Med-DRA, WHO DD and CDD coding, narrative writing, generating follow-up information. 3. Quality review: Involved in checking the consistency of case & valid information in database against the source document.4. Triage: To determining the priority of patients' treatments based on the severity of their condition & prioritizing the case for reporting to authorities.5. QCs of ICSR Case: Performs quality control activities including Oversight QC to ensure complete and accurate case information has been entered into the drug safety database,6. Labelling: Convergent in labelling of the events as per the labelling documents.7. Other : End to end case processing in safety database starting from a data entry, selecting the adverse events, assessing dechallenge and rechallenge and writing descript narratives. Show less

  • Senior pharmacovigilance associate

    Apr 2019 - Mar 2020

  • Pharmacovigilance Associate

    May 2017 - Mar 2019
• 

  Tata Consultancy Services

  Mar 2020 - now

  Process Lead (Global Pharmacovigilance Operations)

  • Proactive work flow management and daily task assignment• ICSR query point of contact, L&P deletion responsible, team production data• Daily planning, assigning and directing work and insure internal, regulatory, LP timelines met also were expedited accordingly• Point of contact to share the trend analysis, deviations, and compliance cases in all safety groups• Preparation and presentation of weekly quality SLA score of team & individual quality, production, training's compliance, field level errors, RCA levels & overall preventive measures and share the same with stakeholder and customers• Participating in teleconference with difference agenda’s such as client interactions, work load, cases discussion, quality analysis, process improvement & other adhocs• Collect, analyses, review and submission of RCA, CAPA & deviation plans to management and fixed them (have basic knowledge of SOPs/service level agreement and key performance in indicators)• I do involved in capacity, resources utilization, steering of new hires, access related and training aspects• Handling team meetings with different agenda like query resolutions, refreshers, mail &, workload discussion• Monitoring quality compliance as well as gaps and initiate appropriate CAPA actions, Cooperate with the groups affiliates, regions and all other stakeholders in order to ensure compliance and inspection readinessSubject Mater Expert/Mentor:• End to end mentoring of new hires-mentees, alignment of mentors to mentee and daily task allocations and WF aligning• Supervision and co-ordination with mentees to understand and train with complete processing handling and release to WFs• Take weekly sign of projections and approval of new hires across location• Conducting sign off review meetings & designing and implementing specific training initiatives to productivity & quality• Process expert global pharmaco and device vigilance, product responsible, PVA and SDEA management, query management Show less