Data Entry Project Manager
Resume:
Navdeep Kaur
Summary of Experience
Four and a half year of experience in Pharmacovigilance including triage, data entry and case assessment, data validation and quality check (QC) of Individual Case safety Reports (ICSRs). Expertise in managing ICSRs of various case types
(spontaneous and clinical cases). Familiar with international drug safety regulations (International council for harmonization of Technical requirements for Pharmaceutical for human Use (ICH), US Food and Drug administration (FDA) guidelines, Council for International Organizations of Medical Sciences (CIOMS), New European Union (EU) Pharmacovigilance (PV) legislation). Mentored pharrmacovigilance scientists in various activities of case processing. PROFESSIONAL EXPERIENCE:
Expertise in management of ICSRs which include:
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.
Registration/initiation of ICSRs into the safety database.
Conducting duplicate searches prior to registration and identifying potential duplicates
Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (Such as Summary of Product Characteristics (SMPC), Company Core Data Sheet (CCDS), Investigator Brochure (IB), etc), writing case summaries, assessing causalities if required and writing company comment if required.
Data validations, i.e. cross checking against source document.
Highlighting any issues emerging from the QC results to the Project Manager/Senior Management.
Maintaining any awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
Expertise in handling PV queries of clinical trials by having access to Rave database.
Experienced in Medical Dictionary of Regulatory Activities (MedDRA) coding in accordance with “MedRA Term Selection: Points to Consider”.
Maintained a good working knowledge of the adverse event (AE) safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including
ICH guidelines on safety and efficacy
GVP guidelines
FDA guidelines
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CIOMS
New EU PV legislation
Experienced in handling the ERP systems (Enterprise Resource Planning).
Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies.
Responding to clients/customers in a timely manner.
Handling ad-hoc requests from client regarding compliance investigations, as applicable
Monitoring the compliance by monitoring the standardized ICSR lateness reasons, as associated.
Corrective and Preventive Action (CAPA), as applicable. Research Experience
June 2016- July 2017
Worked on M.Pharma thesis project “Comparative study of different formulations of Self Emulsifying Drug Delivery System (SEDDS) of Docetaxel.” Education
Chandigarh Group of Colleges, Landran, Master's in pharmacy
(Pharmaceutics), 2017
Chitkara College of Pharmacy, Rajpura, Bachelor's in pharmacy, 2014
Montegomery Gurunanak Public School, 12th Standard, 2009
St. Thomas school, 10th Standard, 2007
Language Skills
English, Hindi, Punjabi: Fluent
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