Richa Kumar Email & Phone Number

Noida, Uttar Pradesh, India

Noida, Uttar Pradesh, India

Experienced in authoring VMP, authoring OQs (for Argus upgrade and Custom Reports), RTM preparation, OPP and VSR drafting.

Gurgaon, Haryana, India

Actively involved in performing quality reviews of various aggregate reports (PBRERs, PSURs, RMPs, DSURs and ACOs). Also, I am working as a medical reviewer for ICSRs. Additionally, I help the team identify quality trends.

Bengaluru, Karnataka, India

Expertise in performing independent retrospective quality reviews on various types of aggregate reports including PBRERs, DSURs and RMPs. Reaching out to various stakeholders for RCA. Drafting debrief memos documenting the RCA and CAPAs. Performing trend analysis.

Chandigarh Area, India

More than 3.5 years of experience in Pharmacovigilance (PV) including triage, medical regulatory assessment, data entry, writing company comments, data validation and QC. Expertise in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, clinical studies, solicited programmes and literature cases). Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation). Trained and… Show more More than 3.5 years of experience in Pharmacovigilance (PV) including triage, medical regulatory assessment, data entry, writing company comments, data validation and QC. Expertise in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, clinical studies, solicited programmes and literature cases). Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation). Trained and mentored PV scientists in various activities of case processing.Authoring of aggregate reports like PBRERs, DSURs and RMPs. Show less

Chandigarh Area, India

I have been primarily working as a Quality Check (QC) scientist but have also been trained as a Case Data Manager (CDM) and Case Medical Evaluator (CME). My principal functional responsibilities include perform the QC of cases for the accuracy of data captured on the client’s database per relevant guidelines and procedures, monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated Corrective and Preventive Action (CAPA) plans, if applicable, mentoring of… Show more I have been primarily working as a Quality Check (QC) scientist but have also been trained as a Case Data Manager (CDM) and Case Medical Evaluator (CME). My principal functional responsibilities include perform the QC of cases for the accuracy of data captured on the client’s database per relevant guidelines and procedures, monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated Corrective and Preventive Action (CAPA) plans, if applicable, mentoring of scientists if and when required among other job roles. Show less

Chandigarh Area, India

I have worked as a Case Data Manager (CDM), Case Medical Evaluator (CME) and Quality Check (QC) scientist. As a CME, I have been responsible for providing medical inputs for assessing and capturing adverse event/events reports associated with client products on a worldwide basis on client’s drug safety database, all performed in accordance with international and local regulatory requirements.As a CDM, I have been involved in capturing of accurate data per the international and… Show more I have worked as a Case Data Manager (CDM), Case Medical Evaluator (CME) and Quality Check (QC) scientist. As a CME, I have been responsible for providing medical inputs for assessing and capturing adverse event/events reports associated with client products on a worldwide basis on client’s drug safety database, all performed in accordance with international and local regulatory requirements.As a CDM, I have been involved in capturing of accurate data per the international and local regulatory requirements. As a QC scientist, I have quality reviewed individual case safety reports (ICSR) for accuracy of the data captured on the client’s database per relevant guidelines and procedures. Also, I have performed compliance investigations in PV monitor tool. Show less

Master Of Science - Ms, Biotechnology

College Gold medalist, with second rank in Panjab University.

Bsc, Biotechnology

Gold Medalist and a scholarship student.

Senior Secondary, Biology, General