Divya Singh

To be a part of a service-oriented industry that values enthusiasm, professionalism, and commitment to perform. Being a firm believer in teamwork, I aim to become a torchbearer for my organization. Hardworking with a cheerful outlook, keen to learn new things, and enjoys working in a team environment. Comprehensive problem-solving abilities, excellent verbal and written communication skills, ability to deal with people, willingness to learn, and team facilitator.

Manager- Clincal Trial Disclosure - Bristol Myers Squibb - Hyderabad, India

(2024-01)

Document Anonymization Manager - GlaxoSmithKline - Bengaluru, India

(2021-06 - 2024-01)

• Redaction and anonymization of clinical documents (HC-PRCI, EMA policy 0070, EMA Policy 43, Japan PMDA, EUCTR, Local Country Regulation Support, and voluntary data redaction etc.)
• Anonymization responsibilities include the preparation of a project forecast tracker, document analysis, PIM preparation, anonymization methodology decision, CCI guidance, anonymization report review, and document review against PI and CCI guidance and rules
• Multiple projects overseeing the delivery of projects within the agreed timelines, project planning and discussion (internal and with vendors), team monitoring, work allocation, and maintenance and update of project trackers
• Expertise in MS Word, Excel, Power Point, Adobe Acrobat Pro
• Coordination with relevant team functions within clinical development and clinical development operations, and other stakeholders to obtain accurate and appropriate information for public disclosure
• Revision and review of training material, guidance documents, SOPs, and templates
• Training plus mentoring internal as well as external team members and conducting inter-departmental knowledge sharing sessions

Medical Writer II (Disclosure support group and medical information) - Syneos Health Clinical Solutions - Gurgaon, India

(2018-12 - 2021-06)

• Results posting of interventional and non-interventional studies on clinicaltrials.gov and EudraCT by developing content from the Clinical Study Report, Statistical Analysis Plan, Protocol, and other regulatory documents that included prospective as well as retrospective data posting, and protocol summaries registration
• Requirement gathering and interpretation of registry or template requirements as appropriate for the study
• Ensure that sponsored study results are disclosed according to applicable laws, regulatory requirements, and policies
• Redaction and anonymization (HC-PRCI and voluntary data redaction)
• Global Medical Information of pharma and consumer health products, inquiry categorization, and handling

Medical Writer Senior Associate (Clinical Trial Disclosure) - Kinapse-India (A Syneos health company) - Gurgaon, India

(2018-03 - 2018-11)

• Results posting of interventional and non-interventional studies on clinicaltrials.gov and EudraCT and protocol summaries registration
• Redaction and anonymization (HC-PRCI, EMA policy 0070, voluntary data redaction)
• Anonymization responsibilities included pre- assessment of documents, preparation of rule sheets, discussion with clients on proposed methodologies, anonymization report writing, and document marking against PI and CCI guidance and rules

Medical Writer Associate (Clinical Trial Disclosure) - Kinapse-India - Gurgaon, India

(2016-08 - 2018-03)

• Redaction and anonymization (HC-PRCI, EMA policy 0070, voluntary data redaction)
• Anonymization responsibilities included pre- assessment of documents, preparation of rule sheets, document marking against PI and CCI guidance and rules

Project Associate (Project Management Team) - Sovereign Health Group - Gurgaon, India

(2015-04 - 2016-08)

• Day-to-day operations, requirement gathering, primary and secondary research, project updates, technical support helpdesk, monitoring and quality checks, medication log designing, EMR template planning and designing, analyzing medical reports, and treatment regimens

Technical Associate (Pharma) - National Institute of Biologicals - Noida, India

(2014-08 - 2015-01)

• Formation of a drug database, secondary research, software testing, data management and analysis, quality control of documents, editing of documents, etc.

Trainee (Pharma) - District Hospital - Bijnor, India

(2013-06 - 2014-06)

M. Pharma - Pharmacology - Rajasthan University of Health Sciences (2014)

B. Pharma - Uttar Pradesh Technical University (2010)

12th - Uttar Pradesh State Board of High School and Intermediate Education (2004)

10th - Uttar Pradesh State Board of High School and Intermediate Education (2002)