Jr Drug Safety Associate Ii - Signal Management

1-3 years

Not Disclosed

Remote

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Key Responsibilities:

Safety Signal Detection and Triage:
- Conduct safety signal detection and triage for a complex portfolio of products.
- Identify new safety signals through comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases and aggregate data analysis.
Expert Evaluation:
- Provide expert analysis of post-marketing signal detection results during cross-functional team meetings, such as Safety Review Meetings and Joint Safety Committees.
Collaboration:
- Work closely with safety leads for respective products.
- Act as a core member of the Signal Management Team, offering expert insights on post-marketing signal detection using both internal and external reporting databases.
Database Searches and Analysis:
- Perform searches in external Health Authority databases (e.g., FAERS, Vigibase, iDAP, DAEN), analyze, and report findings.
- Conduct quality control checks on database searches performed by colleagues.
EudraVigilance Management:
- Oversee EudraVigilance database requests and monitor the database for assigned products.
- Provide training and mentorship to junior Safety Signal Colleagues.
Development of Guidance Documents:
- Lead the development and updating of Business Guidance documents and Standard Operating Procedures (SOPs).
- Contribute to the creation of new approaches for automated signal detection in both internal and external databases.

Qualifications:

Education: Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). An advanced degree is preferred.
Experience: Proven experience in pharmacovigilance or drug safety with a focus on safety signal detection and triage.
Technical Knowledge: Familiarity with post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN).
Skills: Strong analytical and problem-solving abilities with a capacity to evaluate and interpret complex safety data.
Collaboration: Demonstrated ability to work effectively with cross-functional teams and provide expert input in a matrix environment.
Database Management: Experience managing EudraVigilance database requests and conducting quality checks on database searches.
Organizational Skills: Ability to manage multiple tasks and projects simultaneously with strong organizational skills.
Communication: Excellent written and verbal communication skills.
Documentation: Proficiency in developing and updating SOPs and Business Guidance documents.

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Jr Drug Safety Associate Ii - Signal Management

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