Signal Detection and Management
Signal Detection and Management 57
Applications
57
Applications
Ahmedabad
Full-Time
Junior: 1 to 3 years
Posted on Jun 08 2023
Not Accepting Applications
About the Job
Skills
FAERS and WHO-Vigibase data work experience
Pharmacovigilance
GVP Module IX
Hello Jobseekers!!
Greetings From Pharmazone!
We are hiring....
Position- Signal Detection & Management
Location- Ahmedabad
Qualification- B.Pharm/M. Pharm
Experience- 2-3 Years
Job Description-
- Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
- Assess currently utilized quality documents and develop/modify business processes as needed.
- Develop training materials and provide training.
- Develop and implement a consistent process to produce KPIs
- Work closely with PM to ensure that timelines are met.
- Coordinate and lead SMC meetings
Experience:
- 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 integration of 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 Excel/WP/PowerPoint and technical writing skills
- Clinical experience a plus.
If interested kindly share updated CV on - hr@pharmazones.com
Or contact on- 9898778211.
About the company
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Inte ...Show More
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Intelligence & Strategy, Medical Writing, Submission & Publishing, Artwork, Labelling, translation, Health Authority interactions, and all post-approval requirements including an end to end Pharmacovigilance services like case management, Aggregate Reports, Signal Detection, MICC, etc. Our objective is to help large, medium & small-size life science companies in efficient execution & compliance of their drug development plans and Post-Approval Requirements for regulated markets and the developing world. Global Regulatory Landscape is dynamic and our compliance services (GXP) play a vital role for clients. Being a trendsetter in GCP Auditing & Consulting, Pharmazone has successfully carried out 2000+ projects for Clinical Monitoring (Bioequivalence, Late Phase), Study Design, Audits, CRO setup & Up-gradation & Programme Management. Our GMP Solutions include Audits, Report Library, Quality Consulting, USFDA/EMA/PICS/WHO accreditation Support, CSV & Engineering Services including Plant Setup & Upgradation. Though Client's trust is our biggest recognition, our hard work-filled journey has brought us various awards like "Best HealthCare Brand" by CMO Asia -ABP News, Top 10 Clinical Research Provider by Silicon India. "Value Creation by Right solutions is Working Mantra at Pharmazone. The expert team at our global locations (INDIA, USA, CANADA and CHINA) have served 300+ Clients to satisfaction and we look forward to serving you! ...Show Less
Industry
Pharmaceutical Manufactur...
Company Size
51-200 Employees
Headquarter
Ahmedabad
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