Drug Safety Associate Ii

2+ years

Not Disclosed

Mohali

10 Oct. 8, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Drug Safety Support Specialist

Company: Parexel

Overview: At Parexel, our shared goal is to improve global health. Every role contributes to the development of therapies that benefit patients. We work with empathy and a commitment to making a difference.

Key Accountabilities:

Drug Safety Support:
- Assist in developing project-specific safety procedures and workflows.
- Set up safety databases and develop data entry guidelines.
- Triage incoming reports for completeness and validity.
- Ensure electronic documentation and quality control of drug safety information.
- Enter case reports into safety databases and manage queries.
- Code data and write case narratives.
- Maintain project-specific files and assist with various drug safety activities.
- Inform management of potential project scope changes.
- Support medical monitoring activities as needed.
- Participate in client and investigator meetings.
- Conduct literature searches and prepare for audits.
- Delegate tasks to Drug Safety Assistants as appropriate.
- Assist with expedited reporting procedures and regulatory registrations.
- Submit safety reports to investigators and track submission cases.

Skills:

Strong analytical and problem-solving abilities.
Proficient in database and literature searches.
Excellent interpersonal, verbal, and written communication skills.
Strong organizational and prioritization capabilities.
Collaborative team player with a client-focused approach.
Experience with relevant computer applications.

Knowledge and Experience:

Minimum of 2 years of relevant experience in ICSR case processing.

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Drug Safety Associate Ii

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