Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Darshana Jadhav

8.5 Years in Pharmacovigilance
Mumbai

Summary

A highly accomplished Pharmacovigilance professional with 8.5 years of comprehensive experience in ICSR processing, Literature assessment (5 years) and regulatory compliance within the Indian context and global standards. Proven ability to ensure data accuracy, meet timelines, and contribute to effective safety surveillance. Strong understanding of ICH-GCP, and safety databases. Excellent communicator and collaborator, seeking a challenging role to leverage expertise in enhancing drug safety outcomes.

Overview

9
9
years of professional experience
3
3
years of post-secondary education
2
2
Certifications
4
4
Languages

Work History

Drug Safety Scientist I

Qinecsa
Mysore
09.2021 - Current
  • Literature Knowledge : Efficient in Literature cases screening, case processing and training aspects.
  • Case Management Expertise: The list clearly emphasizes core Adverse Event (AE) case processing, from initial review and evaluation to closure. This includes meeting timelines, handling queries, and reconciliation, indicating a strong understanding of pharmacovigilance workflows.
  • Guidance and Mentorship: The responsibilities explicitly mention providing guidance and training to Data Entry, Quality teams, and new team members. This points to leadership potential and the ability to share expertise.
  • Problem Solving and Decision Making: Identifying and resolving issues, conflicts, and reconciliation discrepancies showcases problem-solving skills and the ability to make informed decisions within the scope of internal policies.
  • Team Leadership and Delegation: Delegating tasks and overseeing the activities of other Drug Safety Associates demonstrates leadership capabilities and the ability to manage workload effectively within a team.
  • Compliance and Adherence: Following internal policies, procedures, and departmental workflows underscores a commitment to regulatory compliance and standardized processes.
  • Proficiency and Experience: The mention of a "high level of proficiency at all workflow tasks" suggests significant experience and a deep understanding of the end-to-end AE management process.

Senior Drug Safety Associate

Tata Consultancy Services
Mumbai
05.2019 - 10.2021
  • ICSR Intake and Initial Processing: The primary focus is on managing Individual Case Safety Reports (ICSRs) as they are received through data exchange systems and the IRT module. This includes acknowledging receipt, triaging, and performing initial data entry.
  • Data Accuracy and Completeness: There's a strong emphasis on accurate data capture of key information (reporter, product, patient, AE details) from source documents.
  • Adverse Event Identification and Assessment: The role involves identifying potential AEs within source documents and making initial assessments of seriousness, adhering to established guidelines.
  • Compliance and Timeliness: Maintaining compliance with regulatory and internal timelines is a critical aspect, requiring proactive workflow management.
  • Quality Control and Reconciliation: Performing duplicate searches, handling invalid items, sending queries, and conducting manual reconciliation activities (CTV/SDQC) demonstrate a commitment to data quality.
  • Communication and Escalation: Identifying and forwarding specific types of documents (product quality complaints, STIAMP, translation needs, legal documents) to the appropriate teams (US Drug Safety) highlights the importance of inter-departmental communication.
  • Follow-up Management: Identifying the need for and drafting follow-up letters indicates responsibility for gathering further information.
  • System Proficiency: The role requires a strong understanding and efficient use of the IRT module and likely ARIS.
  • Knowledge and Compliance: Maintaining knowledge of safety concepts, regulations, SOPs, disease biology, and Roche product information is essential.
  • Training and Mentoring (when assigned): The responsibility to train case managers for IRT entry indicates potential for mentorship and knowledge sharing within the team.
  • Inspection Readiness: Ensuring training records are up-to-date and potentially representing the team in audits highlights the importance of compliance and audit readiness.
  • Collaboration: Proactively collaborating with relevant personnel to stay informed about critical safety information demonstrates a commitment to continuous learning and proactive safety management.

Junior Data Analyst

Cognizant Technology Solutions
Mumbai
02.2016 - 05.2019
  • Familiar with all type of source documents, guidelines related with special adverse events, coding guidelines and data handling guidelines.
  • Familiar with all type of event terminologies and how to avoid the operational errors during processing. Processing individual case safety reports (ICSR) from various sources such as Literature (Clinical and spontaneous), Partner Clinical, Non-interventional studies, Spontaneous and E2B cases as per meeting the regulatory timelines.
  • Identification of duplicate records, initiations of cases and case processing in database.
  • Duplicate search and importing of E2B case from the E2B gateway.
  • Acknowledging receipt of all ICSRs to sender within the timelines.
  • Medical coding of events as per (MedDRA) and drugs (WHO-Drug Dictionary), causality assessment.
  • Sending MedDRA requests as needed and discussing with operation physician team regarding the amendment/split and raising queries regarding the events.
  • Evaluating seriousness, causality assessment and expectedness assessment as per Company Core data sheet (CCDS), Canadian Product Monograph (CAPM), Summary of Product Characteristics (SmPC or SPC), United States Package Insert (USPI) and Information Brochure (IB).
  • Mentoring and peer QC of the newly joined associates for initiating the receipt items in Inbound receipt Triage (IRT).

Education

Bachelor of Pharmacy - Pharmacy

K.M.Kundnani College of Pharmacy (Mumbai University)
Mumbai
06.2009 - 02.2012

Skills

Literature assesment

Databases (Argus and Arisg)

Regulatory Knowledge and Compliance

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Certification

Prompt Enginerering

Timeline

Prompt Enginerering

04-2025

Knowledge of German language

04-2025

Drug Safety Scientist I

Qinecsa
09.2021 - Current

Senior Drug Safety Associate

Tata Consultancy Services
05.2019 - 10.2021

Junior Data Analyst

Cognizant Technology Solutions
02.2016 - 05.2019

Bachelor of Pharmacy - Pharmacy

K.M.Kundnani College of Pharmacy (Mumbai University)
06.2009 - 02.2012

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Darshana Jadhav8.5 Years in Pharmacovigilance