Synopsis: Over * years of professional experience in managing various drug safety cases as a Senior Pharmacovigilance scientist.

EXPERIENCE SUMMARY

Having more than 3 years of progressive experience in managing and processing various Clinical, spontaneous, literature, drug surveillance, Summary, Licensee, Regulatory authority cases.

Knowledge of drug development, phases of clinical trials and clinical research.

Excellence in Clinical, theoretical and practical knowledge.

Knowledge of ICH, GCP Guidelines and FDA guidance documents.

Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.

Expertise in clinical narrative writing and literature case review and coding.

Expertise in managing safety data on various safety databases.

Knowledge of literature cases.

Proficiency in using/handling ADVENT, IRT, ERP.

Proficiency in MS Office (word, excel, PowerPoint), outlook.

Proficient in writing SQL queries using Microsoft SQL server 2000.

Knowledge of SAS base software.

Strong written and verbal communication skills.

MEDRA coding, labeling, Case Intake and triage, tracking regulatory updates concerning the product safety and efficacy.

Knowledge of processing of pregnancy cases and maternal cases.

Sound evaluative/analytical skills required for processing complex adverse event cases.

Possesses the important feature of Quality and thoroughness as cases submitted to health authorities.

Hands-on role with drug safety database, so have good understanding of pharmacovigilance databases.

Sound knowledge of pharmacovigilance (including UK and EC regulations) and high awareness of global nature of drug safety.

Life science degree.

Proven pharmacovigilance experience.

Experienced in processing literature cases. Review of global literature and return for translation if required. Evaluation of weekly literature searches to identify case reports and safety data of interest.

Worked on a project for EMEA concerning duplicate detection.

QUALIFICATION

INTERNSHIP EXPERIENCE:

One year rotating internship training from M.N.DAV DENTAL COLLEGE.

WORK EXPERIENCE

Worked with Quantum Solutions, India from Mar 2008 – Apr 2011

Role : Senior Pharmacovigilance Scientist.

Tools Used : Advent, ERP, IRT

Description:

#1: Management of Individual Case Safety reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs).

Role and Responsibilities:

Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.

Initiation of ICSRs into the safety database.

Conducting duplicate searches prior to initiation and identifying potential duplicates.

Managing duplicate couples/cases appropriately.

Coding of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents such as SPC, CDS, IB, etc., writing case summaries, assessing causalities if required and writing company comment if required.

Data validations i.e. cross checking against source documentation.

Maintaining excellent knowledge of the AE safety profile of assigned drugs, Reference safety information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including

ICH guidelines on safety and efficacy.

Volume 9a.

FAD guidelines.

CIOMS.

Coded over 3500 cases till date.

Handled 225+ products and 300+ studies.

Worked on old cases, projects, reconciliations.

#2: Working on Client live database

Involves management and processing of Adverse drug reaction cases (ADR), spontaneous cases, Literature cases, Serious Adverse Event (SAE) analysis from clinical trials as well as post marketing licensee partners.

Role and Responsibilities:

Actively involved in LABELING and assessment of seriousness and expectedness/listedness of AE’s, Causality Statement.

Ensure all cases meeting strict timelines as defined in global operating procedures are processed daily, aiming for 100% compliance

Maintaining a constant state of readiness for any inspection activity related to business / CSE functional areas of responsibility

Involved in Training of the new employees.

#3: Literature Experience:

Has been processing literature cases for more than one and a half year.

Has processed over 1200+ literature cases till date.

Has experience in review and validity assessment of articles, triage, duplicate searches, registration, MedDRA coding, AE text writing, QC of literature (both clinical and spontaneous) reports, Query identification and tracking, adding of company comments.

Literature cases includes cases from medical journals, abstracts, poster, presentations, literature summary cases and full literature articles including clinical cases (including interventional and non- interventional case studies) and spontaneous reports.

Has been communicating with the authors of the articles for the required information. Has experience in review and validity assessment of articles, triage, duplicate searches, registration, MedDRA coding, AE text writing, QC of literature (both clinical and spontaneous) reports, Query identification and tracking, adding of company comments.

#4: Experience in Therapeutic areas:

Oncology.

Infections and infestations.

Dermatology.

Cardiovascular.

Rheumatology.

Immunology/Autoimmune diseases.

Metabolic disorders.

Hematology.

Virology.

Psychiatric and CNS Disorders.

#5: Other Areas of Expertise:

Report nullification (decision making and processing) and case merging into a Master case.

Reconciliation of safety and clinical databases.

Clinical narrative writing.

Literature case review and coding.

#6: Quality and Query Management Roles and Responsibilities:

Quality Control/Quality Review: performing quality checks of ICSRs to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements.

Interacting with appropriate client personnel to resolve issues related to the processing of the ICSRs in accordance with clients’ policies.

Responding to clients in a timely manner.

Personal Details:

Name as in Passport : Rashmi Thakur

Email id (Hex & Personal) : auyou1@r.postjobfree.com

Mobile No : 253-***-****

Landline No : 206-***-****

Date of Birth : 13-Aug-1983

Passport No : H9033293

Passport Expiry Date : 30-Aug-2020

Visa Status : L2

Marital Status : Married

Nationality : Indian

Sex : F

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