KenoshaRecruiter Since 2001
the smart solution for Kenosha jobs

Medical Safety Reviewer/RN pref/Pharma DrugSafety exp

Company: Asen-LG Associates
Location: Kenosha
Posted on: July 10, 2019

Job Description:

Medical Reviewer/Safety Reviewer/RN pref/Pharma DrugSafety exp 4291 22-28.00 an hour w2 contract 03/18/2019 to 03/17/2020 NOTE: Manager is looking for candidates with Pharma experience, preferably an RN. Participates in applicable safety surveillance activities for assigned products; and in planning and completion of AdHoc Safety Reports as needed. Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution. Supervise tracking of safety related queries to Investigators and assists in handling safety questions from IRB/IEC. Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data. Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency. Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment. May serve as a representative for Safety Management on cross functional projects, but does not assume decision making responsibilities in the representative role; Contacts may include Clinical Safety Manager and a variety of multidisciplinary representatives (e.g. Regulatory Affairs, Quality Assurance, Compliance). Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction Workload responsibilities are primarily study related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager. Qualifications : Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered. Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience. Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., Oracle/clinical, PIMS, laboratory databases). Ability to critically evaluate medical data. Ability in accurately and medically presenting; of case data, both orally and in writing. Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence. Monitor problems through resolution. Analyze and interpret adverse event data as a component of clinical surveillance activity. Consistently exercise good judgment within policies and regulations.

Keywords: Asen-LG Associates, Kenosha , Medical Safety Reviewer/RN pref/Pharma DrugSafety exp, Healthcare , Kenosha, Wisconsin

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


RN Care Coordinator - PRN Registry (Hoffman, IL)
Description: We Are Hiring RN Care CoordinatorPRN Registry - Weekday availability Mon - Fri AMITA Health: Saint Alexius Medical Center Hoffman Estates, IL Why Join AMITA AMITA Health www.AMITAhealth.org is a (more...)
Company: AMITA Health
Location: Hoffman Estates
Posted on: 07/17/2019

Healthcare Benefits Specialist
Description: We are currently interviewing peopleTODAYto work at home To Request an Interview, please visitwww.millionairemommy7.com We provide training through the internet or through telephone conferences. We help (more...)
Company: TQS
Location: Sheboygan
Posted on: 07/17/2019

RN - Chemical Dependency - Alexian Brothers Behavioral Healt
Description: We Are Hiring RN-Behavioral Health - Chemical Dependency 001 - Part-Time,Evening - AMITA Health ABBHH - Hoffman Estates,ILWhy Join AMITA AMITA Health www.AMITAhealth.org is a joint operating company (more...)
Company: AMITA Health
Location: Hoffman Estates
Posted on: 07/17/2019


RN Jobs - All Specialties - HealthCareTravelers.com (Hoffman Estates,I
Description: Registered Nurse. Travel Nurse
Company: HealthCare Traveler Jobs
Location: Hoffman Estates
Posted on: 07/17/2019

RN - Telemetry - SAMC Hoffman Estates (Registry/PRN Night) -
Description: We Are Hiring RN-Float - Cardiology Unit 001 - PRN,Night - AMITA Health SAMC - Hoffman Estates,ILWhy Join AMITA AMITA Health www.AMITAhealth.org is a joint operating company formed by the Adventist (more...)
Company: AMITA Health
Location: Hoffman Estates
Posted on: 07/17/2019

Behavioral Health Associate - PRN/As needed, Nights, Hoffman
Description: We Are Hiring Behavioral Health Associate - Adlt Psychiatry Nrsng Unit 001 - PRN,Night - AMITA Health ABBHH - Hoffman Estates,ILShift: position will be as needed shifts for staff coverage and times (more...)
Company: AMITA Health
Location: Hoffman Estates
Posted on: 07/17/2019

Occupational Therapist - OT part time - Crystal Lake, IL
Description: DescriptionKindred RehabilitationServices is the largest diversified provider of rehabilitation therapy in the country. Through RehabCare and Kindred Hospital Rehabilitation Services, we provide leading (more...)
Company: Kindred Rehab Services
Location: Crystal Lake
Posted on: 07/17/2019

Physician: Gastroenterology Physician is Needed for Locum Tenens Assis
Description: We are providing locum tenens staffing assistance to a Wisconsin-based medical center that is currently seeking a gastroenterologist to assist with temporary
Company: CompHealth
Location: Sheboygan
Posted on: 07/17/2019

Caregiver - Set Your Own Schedule!
Description: Who Were Looking For: We are seeking reliable, compassionate, and upbeat CNAs and Caregivers who can provide In Home care, personal care, and companionship. Many of our clients are looking
Company: CareInHomes
Location: Carol Stream
Posted on: 07/17/2019

Travel - ALLIED - Allied Health Professional/SLP - Speech Language Pat
Description: Come work at LRS Healthcare, the leading company in our industry. Were proud of our 4.7 rating on Glassdoor and 4.6 rating on Indeed. We are seeking to hire a talented traveling Acute Care / Hospital (more...)
Company: LRS Healthcare
Location: Sheboygan
Posted on: 07/17/2019

Log In or Create An Account

Get the latest Wisconsin jobs by following @recnetWI on Twitter!

Kenosha RSS job feeds