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Profile Details

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USD 40 /hr

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Hire ikra r.

India

USD 40 /hr

Freelancer Pharmacovigilance Safety specialist with 1 year of hospital experience and 3 years in a well reputed CRO, IND

Profile Summary

1. Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance.

2. Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project specific safety plans.

a) Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability. 
b) Enters data into safety/adjudication database. 
c) Performs Quality Control (QC) of entered data/endpoint dossiers. 
d) Codes events, medical history, concomitant medications and tests. 
e) Compiles complete narrative summaries. 
f) Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved. 
g) Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. 
h) Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.

3. Assists safety project lead/endpoint manager in the preparation of a safety management plan.

4. Distributes all required periodic reports for both clinical and post-marketing projects.

5. Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements.

6. Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.

7. Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.

8. Maintains knowledge of ongoing projects and disease-related terminology.

Subject Matter Expertise

Services

Writing
Research
Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis, Data Visualization

Work Experience

Safety Specialist II

Syneos Health

November 2017 - Present

Education

Masters in Pharmacology

Dr. APJ Abdul Kalam University

November 2015 - July 2018

Certifications

Certification details not provided.