Drug Safety Associate Ii

2+ years

Not Disclosed

Mohali

10 Sept. 7, 2024

Job Description

Job Type: Full Time 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

Drug Safety Support Specialist

Responsibilities:

Assist in developing project-specific safety procedures, workflows, and templates.
Support the setup of project-specific safety databases, including developing data entry guidelines and conducting user acceptance testing.
Triage incoming safety reports for completeness, legibility, and validity.
Ensure electronic documentation and quality control of drug safety information.
Enter case reports into safety databases and tracking systems.
Manage follow-ups and queries, including coding data and writing case narratives.
Create and maintain project-specific working files, case report files, and central project files.
Assist with additional Drug Safety Specialist and Safety Service Project Leader (SSPL) tasks as needed.
Inform Line Manager, Safety Services Project Leader (SSPL), or Project Leader (PL) and Regional Head of PV Operations about potential project scope changes.
Support Medical Directors/Safety Physicians with medical monitoring activities as required.
Participate in client and investigator meetings and attend internal drug safety and project-specific training sessions.
Conduct literature searches and prepare for, participate in, and follow up on audits and inspections.
Delegate tasks to Drug Safety Assistants as appropriate.
Assist in developing expedited reporting procedures and with electronic reporting registration on behalf of sponsors.
Help set up and deploy worldwide reporting to regulatory authorities, CECs, local ECs, and investigator sites, both electronically and in hard copy.
Submit safety reports to investigators via ISIS (International Safety Information System).
Measure investigative site performance in conducting required tasks in ISIS and track and file submission cases as needed.
Assist with unblinding of SUSARs and support the collection and review of metrics for reporting compliance.

Skills:

Strong analytical and problem-solving abilities.
Proficient in database and literature searches.
Excellent interpersonal, verbal, and written communication skills.
Highly organized with strong prioritization skills.
Collaborative team player with a client-focused approach.
Proficient in computer applications, including Microsoft Excel and PowerPoint.

Knowledge and Experience:

Related experience in a healthcare environment is advantageous.
Minimum of a Bachelor’s Degree in a relevant discipline (e.g., Science, Medical) with 3 years of pharmaceutical industry experience, or 2 years of pharmacovigilance experience.
Experience in quality, compliance, or case processing roles is highly desirable.
Understanding of GxP requirements and global pharmacovigilance preferred.
Ability to function effectively in a global matrix environment.
Excellent communication and writing skills with the ability to manage and resolve issues independently.

Education:

Bachelor’s Degree in a relevant field (e.g., Science, Medical) with 3 years of pharmaceutical industry experience, or 2 years of pharmacovigilance experience.

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Drug Safety Associate Ii

Job Description

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