CHANDANBIR KAUR
Summary
Dynamic Patient Safety Associate II with more that 7 years of experience in Drug Safety, adept at managing complex case processing and ensuring regulatory compliance. Proven track record in quality assurance and data accuracy, complemented by strong organizational skills and a commitment to ethical healthcare practices. Skilled in triage and regulatory submissions, driving safety data integrity.
Overview
7
7
years of professional experience
2
2
Certifications
Work History
Patient Safety Associate II
Parexel International India Private Limited
05.2022 - Current
- Managed end-to-end case processing in safety databases, ensuring accuracy and regulatory compliance for complex Individual Case Safety Reports (ICSRs).
- Led mailbox management and triage, prioritizing cases based on seriousness and reporting timelines.
- Performed and oversaw follow-up activities, ensuring timely and complete collection of safety data.
- Prepared, reviewed, and supported regulatory submissions in accordance with global and local requirements.
- Applied advanced quality assurance checks to identify trends, discrepancies, and support corrective actions and preventive actions.
- Ensured compliance with ICH-GCP, pharmacovigilance regulations, and internal SOPs during inspections and audits.
- Conducted scientific evaluations of adverse drug reactions from clinical trials and post-marketing surveillance.
- Assessed regulatory submissions of safety cases for Health Authorities by reviewing adverse events and causality.
- Analyzed root cause data and identified opportunities for improvement.
- Ensured all documentation is accurate, complete, and compliant with current regulations.
- Developed and maintained databases for efficient data retrieval and management.
- Ensured compliance with data protection regulations in all information handling activities.
Patient Safety Associate I
Parexel International India Private Limited
12.2018 - 04.2022
- Aggregated data for client presentations, focusing on adverse events and literature screening.
- Upheld compliance with ICH-GCP, FDA guidelines, and EU GVP protocols.
Interacted with global stakeholders to manage complex safety inquiries efficiently. - Guided junior pharmacovigilance team members while supervising case handling processes.
Tracked global regulatory obligations to organize work ensuring adherence to reporting deadlines. - Skilled in authoring and maintaining study-specific guidance documents, product reference documents (SmPC, USPI, CDS), and contributing to Investigational Medicinal Product Dossiers (IMPD) and Investigator's Brochure (IB).
- Demonstrated expertise in the critical review of clinical trial, Spontaneous, Non-Interventional study, Managed Access Programme and Literature protocols, informed consent forms (ICFs), and safety-related documents to ensure alignment with global regulatory requirements (EMA, FDA, MHRA, TGA and PMDA).
- Engaged in direct communication with clients, Heath Authorities and regulatory agencies to clarify safety requirements, submission queries, and compliance documentation, fostering transparent and proactive relationship management.
- Collaborated with clinical teams to address safety concerns and implement solutions.
- Reviewed incident reports and provided analysis for risk assessment initiatives.
- Engaged with patients to gather feedback on safety practices and experiences.
- Conducted patient safety risk assessments to identify potential hazards and mitigate risks.
Education
Master's degree - Microbial Biotechnology
Panjab University
Chandigarh, IndiaBachelor's degree - Medical with Biotechnology Elective
Panjab University
Chandigarh, IndiaSkills
- Health information management
- Clinical documentation accuracy
- Data entry proficiency and validation
- Experienced in Safety databased like Argus Safety, Aegis, Veeva Vault and iMedidata
- Electronic health systems expertise
- Quality assurance practices in healthcare
- Processing of confidential health records
- Detail-oriented documentation management
- Ability to work independently or collaboratively
- Effective time management strategies
- Discretion in patient information handling
- Commitment to ethical healthcare standards
- Monitoring adverse drug reactions effectively
- Analysis of safety data in clinical settings
- Oversight of clinical trials processes
- Post-marketing surveillance activities
- Triage and assessment capabilities in cases
- Pharmacovigilance knowledge base
- Familiarity with ICH-GCP guidelines
- Understanding of Therapeutic Goods Administration (TGA) regulations and guidelines
- Understanding of FDA regulations
- Expertise in EU GVP modules
- Patient follow-up protocols
- Regulatory submission expertise
- Team management
Certification
VETASSESS - Positive skill assessment for Life Scientist NEC.
Timeline
Patient Safety Associate II
Parexel International India Private Limited
05.2022 - Current
Patient Safety Associate I
Parexel International India Private Limited
12.2018 - 04.2022
Master's degree - Microbial Biotechnology
Panjab University
Bachelor's degree - Medical with Biotechnology Elective
Panjab University