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Standard job listing
Title of job: Clinical Safety Officer
Job Location: Malvern, Pennsylvania, 19355
Job Type: Contract
Price Range:
Negotiable, Depending on experience
Start Date:
ASAP
End Date:
Not a pressing concern
Categories:
# Section Category Subcategory
#1 Health Care Health Care Pharmaceutical - Clinical
Qualifications:


Other desired skills:
Clinical Safety Officer
Job/Project Details: Our client, located in Malvern, PA is seeking a Clinical Safety Officer for an immediate 6 month position. Details include: Duties: The Local Safety Officer is responsible for processing of SAES according to the Code of Federal Regulation and the Corporate and Local SOPs. The Safety officer is the primary local contact for Global Pharmacovigilance & Epidemiology (GPE) concerning Pharmacovigilance activities or matters in clinical studies. - Ensures that all Safety Information (initial and follow-up) are adequately completed and followed. - Ensure that GPE is informed of any question already asked to Investigators and answer sought. - Ensure that all data initial and follow-up are forwarded to GPE according to the timelines defined in GPE-SOP. - Ensures queries are addressed in preparation of datalock. - Reviews closed cases to confirm archiving readiness and archives as per local filing procedure. Skills: - Good interpersonal skills, attention to detail. - Good verbal and written communications skills. Self-motivated, flexible, adapts to daily work volume while maintaining timelines. - Knowledge of Medical Terminology and disease pathology for review of safety information and preparation of communication to Investigators. - Understanding of Pharmacovigilance operations including ICH/FDA regulations concerning safety reporting preferred. Education: Bachelor degree with 4 to 5 years biological or medical experience (RN, or other related field). Manager would prefer to see candidates with a Nursing/Medical background with drug safety experience working on clinical trials or candidate with strong safety background in clinical trials. About clinicalBROKERS: Headquartered in Princeton, New Jersey, clinicalBROKERS is a full service staffing solutions company dedicated to providing qualified clinical professionals to our clients. clinicalBROKERS provides Consulting/Contract, Contract to Hire, Full Time Permanent, and Project Outsourcing Solutions. Our thorough candidate pre-screening process allows us to present the most qualified professionals for any staffing need. Our success is a result of strong client partnerships where we have a solid understanding the corporate structure of our clients and how our candidates can contribute to their business. In addition, our solid relationships with our candidates allow us to find the best suited environment and opportunity for each individual. Our consultants select us for the personal touch and thorough understanding of what a professional needs. They prefer to work with a company that prides itself in working with only the best people in the highest ethical manner. They know we strive to find for them the best opportunity full of exciting challenges, experience and most importantly, an opportunity to advance their career. clinicalBROKERS consultants have the ability to take advantage of the following benefits: Insurance The following benefits are available for your overall wellness: - Group Health Insurance, Group Dental Insurance, Group Vision Insurance - Short Term Disability Plan, Long Term Disability Plan - Basic Life Insurance - Flexible Spending Accounts, Health Savings Account ; 401K Plan Direct Deposit Employee Service Center The Employee Service Center is a dedicated, toll-free hotline where you can get fast answers to your questions and assistance with a wide range of benefits or payroll related concerns. - Benefit Elections - Payroll Questions - Benefits Confirmation - W-2 Questions - Assistance with Benefits Claims - 401K - Cobra - Rights - Status Change Referral Bonus Program Loyalty and Longevity Bonus Program To review our credentials and accolades please go to our website: www.clinicalbrokers.comdf-jb

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