Medical Safety Reviewer/RN pref/Pharma DrugSafety exp
Company: Asen-LG Associates
Posted on: July 10, 2019
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
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