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Precision Value & Health
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Safety Specialist II

Safety Specialist II

Precision Value & Health

5 years

0 Lacs

bangalore urban karnataka india

Posted:18 hours ago| Platform:

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Skills Required

management development reporting interfacing design assessment database capture triage data coding composition reports regulations qc training processing writing oncology communication recruiting

Work Mode

On-site

Job Type

Full Time

Job Description

Safety Specialist II -
Location: Bangalore Karnataka IndiaBangalore Karnataka IndiaJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 6003Position SummaryResponsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.Essential functions of the job include but are not limited to

Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
Participate in the assessment and set-up of a safety database to capture SAE data.
Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
QC of documents and safety reports.
Preparation and/or review of project‑specific safety reporting plans and medical coding plans.
Preparation and/or review of safety training materials.
Provide safety training and oversight for consultants, contractors and/or staff.
Review and/or draft standard operating procedures and work instructions.
Assist clients and/or other departmental staff with safety-related reviews and other services.
Other duties as assigned.

Qualifications

Minimum Required:

BA/BS degree
Minimum 5+ years safety experience

Other Required:

Health care professional
Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.

Preferred:

Nursing or pharmacy degree preferred
Clinical trial safety experience
Hands on experience with Argus
Industry experience in CRO or pharmaceutical company preferred

Preferred:

Early phase oncology clinical trial experience

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
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Safety Specialist II