Harshpreet Kaur Email & Phone Number | Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, solicited programs) which includes: -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/registration of ICSRs into the safety database. -Conducting duplicate searches prior to initiation and identifying potential duplicates -Managing duplicate couples/cases appropriately -Data Entry of ICSRs in the safety database (ARISg), including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities. - “Distribution and Submissions” of ICSRs to various Health Authorities. • Experienced in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider” • Experienced in handling the ERP (Enterprise Resource Planning) systems. • Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations.

Harshpreet Kaur

Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous,...
Chandigarh, Chandigarh, India

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Harshpreet Kaur’s Phone Numbers +1 781-434-****

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Harshpreet Kaur’s Location Chandigarh, Chandigarh, India

Harshpreet Kaur’s Current Industry Parexel

Harshpreet Kaur’s Prior Industry Sri Sukhmani Dental College And Hospital | Pledge A Smile Ngo

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Drug Safety Associate 1

Present

Drug Safety Associate 1

2021-06-01 00:00:00 - Present

Dental Surgeon

2021-02-01 00:00:00 - 2021-06-01 00:00:00

Fund Raising Intern

2021-02-01 00:00:00 - 2021-03-01 00:00:00

No Skills Available

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Harshpreet Kaur is a Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, solicited programs) which includes: -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/registration of ICSRs into the safety database. -Conducting duplicate searches prior to initiation and identifying potential duplicates -Managing duplicate couples/cases appropriately -Data Entry of ICSRs in the safety database (ARISg), including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities. - “Distribution and Submissions” of ICSRs to various Health Authorities. • Experienced in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider” • Experienced in handling the ERP (Enterprise Resource Planning) systems. • Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations.

Harshpreet Kaur has prior
experience in the following industries:
Sri Sukhmani Dental College And Hospital | Pledge A Smile Ngo

Harshpreet Kaur has the following professional experience:
Parexel International | Parexel | Sri Sukhmani Dental College And Hospital | Pledge A Smile Ngo