Profile
Mahak D. - 17444 Medical Writer from Canada
Completed
0
Assigned
0
Invites
0
Posted
0
Payments
$0.00
Rate/hr
$18.24
User ID
Mahak D. - 17444
Mississauga, Canada
6:56 AM, GMT -04:00

Mahak D. - 17444 Medical Writer from Mississauga

About

Experienced in preparation of PSRs including Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Safety Statements and Semi-Annual Safety Reports (SASRs) and checking of International Non-proprietary Names (INNs) for inclusion in a PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs). • Responsible for maintaining liaison with relevant client personnel for obtaining contributions for different sections of the PSR, for raising and resolving doubts and discrepancies in the data and for coordinating review of the report. • Responsible for maintaining overall consistency of data within different sections of the PSRs. • Experienced in performing quality check of PSRs. • Experienced in international drug safety regulations including ICH guidelines, good pharmacovigilance practice (GVP) guidelines, FDA guidelines and CIOMS. • Maintaining an awareness of global regulatory obligations and organizing workload to ensure compliance with internal and regulatory timelines Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”. • Experienced in handling ERP (Enterprise Resource Planning). • Collaboration with management team to provide training to Medical Writers • Experienced in mentoring junior medical writers • Lead meeting with client and other writer to discuss regarding the authoring of reports • Managing reports based on timelines and ensuring to deliver the reports before the deadline
Occupation

Medical Writer

Work experience
2020 - 2022
Associate Medical Writer
Parexel International
2019 - 2020
Drug Safety Officer
Parexel
Education
2022 - 2023
Humber College
Graduate Certificate
2017 - 2019
Himachal Pradesh University
Master of Science
2014 - 2017
Delhi University
Bachelor of Science
Calendar
September 2022
SU M TU W TH F SA
Available
Unavailable

Skills

Assays
2 Y
DSUR
2 Y
Immunization
2 Y
Immunology
2 Y
In Vitro Studies
2 Y
Mentoring
2 Y
Pharmacovigilance
2 Y
Quality Control
2 Y
Research Ethics
2 Y
Risk Analysis
2 Y
Standard Operating Procedure
2 Y

Other skills

Diphtheria
Service Component Architecture
Syphilis

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