KANIKA TUTEJA
Medical Writer
Chandigarh
Summary
Experienced Medical Writer with 5+ years of expertise in pharmacovigilance and medical writing. Specializes in end-to-end safety signal management processes, including signal detection, prioritization, validation, evaluation, analysis, and assessment. Proficient in generating Safety Evaluation reports, Health Hazard Evaluation Reports, PBRERs, and RMPs. Skilled in crafting medical conclusions and company comments for safety reports. Recognized for meticulous attention to detail and accuracy when handling Individual Case Safety Reports (ICSRs) for client products. Demonstrates ability in conducting comprehensive literature reviews and synthesizing scientific information to support safety evaluations. Proficient in data management and analysis using Microsoft Office, Argus/Aegis, and various pharmacovigilance databases.
Overview
2025
2025
years of professional experience
4037
4037
years of post-secondary education
2
2
Certifications
3
3
Languages
Work History
Medical Writer I
Parexel
2 2024 - Current
- Experienced in performing Signal Detection activities
- Writing SERs/HHEs for a specific topic provided by the Client
- Review of all the source data for specific SER/HHE including review and assessment of cases from client's safety database, review of textbooks and literature publications
- Providing data for Section 16.4 (Characterization of Risks) in PBRER
- Experienced in review and validity assessment of literature abstracts and full articles
- Additionally, their assessment with special focus on Benefit-Risk Evaluations
- Providing oversight/review to other authors
Associate Medical Writer
Parexel
02.2022 - 01.2024
- End to end signal Management
- Authored several SER/HHE including review and assessment of cases from client's safety database, review of textbooks and literature publications.
- Experienced in review and validity assessment of literature abstracts and full articles.
Drug Safety Associate
Parexel
08.2019 - 01.2022
- Experienced in management of Individual Case Safety Reports of all case types (spontaneous, literature cases and solicited programs) including:
- 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
- Book-in of ICSRs into the safety database
- Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SmPC, CDS, IB etc.), writing case summaries, case narrative, assessing causalities if required and writing CIOMS comments if required
- Experienced in MedDRA coding
- Experienced in processing literature cases including cases from medical journals abstracts, poster presentation, literature summary cases and full literature articles including clinical cases (including interventional and non-interventional case studies) and spontaneous reports
Education
Masters - Systems Biology And Bioinformatics
PANJAB UNIVERSITY
Bachelors - Bioinformatics (HONS.)
D.A.V. COLLEGE
Skills
Medical Writing Knowledge
Microsoft Office Proficiency
Data Assessment
Narrative Writing
Time Management
Communication
Client Handling
Quality Control
Problem Solving
Certification
Pharmacovigilance course, 2019
Accomplishments
Gold Medalist in BSc (Hons) Bioinformatics.
Timeline
Associate Medical Writer
Parexel
02.2022 - 01.2024
Drug Safety Associate
Parexel
08.2019 - 01.2022
Medical Writer I
Parexel
2 2024 - Current
Masters - Systems Biology And Bioinformatics
PANJAB UNIVERSITY
Bachelors - Bioinformatics (HONS.)
D.A.V. COLLEGE
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