Signal Detection Manager

2-3 years years

upto 7.5 LPA

Ahmedabad

7 July 15, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD 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: Pharmacovigilance Position - Signal Detection and Management

Location: Ahmedabad

Designation: Signal Detection and Management

Job Description:

Assist the Signal Management Lead in developing new signal detection processes and making changes to the signal tracking tool.
Assess currently utilized quality documents and develop or modify business processes as needed.
Develop training materials and provide training sessions.
Develop and implement a consistent process to produce Key Performance Indicators (KPIs).
Work closely with Project Manager (PM) to ensure timelines are met.
Coordinate and lead Signal Management Committee (SMC) meetings.

Experience Requirements:

Experienced in signal detection tools and processes.
Skilled in implementing new business processes and technology solutions for signal detection in clinical development.
Experienced in LEAN methodology.
Working knowledge of regulations related to signal detection (GVP Module IX).
Proven expertise working with FAERS and WHO-Vigibase data.
Ability to review complex information to develop business-related strategies for integrating clinical development data and real-world data in the signaling process.
At least 2-3 years of pharmacovigilance experience, especially in signal detection and management.
Strong consulting experience.
Excellent skills in Excel, Word Processing (WP), PowerPoint, and technical writing.
Clinical experience is a plus.

Experience: 2-3 years

Qualification: M. Pharm / B. Pharm

Apply: Share your resume at hr@pharmazones.com

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Signal Detection Manager

Job Description

Job Title: Pharmacovigilance Position - Signal Detection and Management

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