Medical Reviewer/Safety Reviewer II
•Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
•2 years clinical experience is required.
•Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
•Sound understanding of product labeling/literature, including safety profile.
•Able to apply clinical knowledge to adverse event data collection and assessment.
•Competent in ability to present adverse event data, orally and in writing.
•Adheres to policies and regulations.
•Must be Computer proficient (Windows, Word, Excel).
Collects, analyzes and triages adverse events and reviews safety-related data from clinical trials. Adherence to regulatory guidance, Protocols, and departmental processes under minimum supervision as this position could impact safety signal identification and patient safety. •Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.
• Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager.
•Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up.
•Timely assessment of adverse event coding for consistency and accuracy of coding.
•Timely, accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians.
•Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance to assure query resolution.
•Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
•Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research organization, clinical research associates, data management, and pharmacovigilance.
•Responsible for clinical safety capture and report, as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile.
•Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of clinical safety that impact product approval, safety signal identification, and patient safety.
Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. 3-5 Years Experience Level.
NOTES FROM INTAKE CALL:
1) What hours and days will this person be working?
2) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1:
b. Required Skill 2:
c. Required Skill 3:
d. Required Skill 4:
e. Required Skill 5:
3) What years of experience, education, and/or certification is required?
4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
5) What is the environment that this person will be working in (i.e. group setting vs individual role)?
6) Is any testing required for this role?
7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?
8) Other notable details from the hiring manager about this role