Medical Reviewer/Safety Reviewer II Job at Planet Group, Illinois

WElpN2owUFlXQWJSaDJ4K1htSUVpUVd2
  • Planet Group
  • Illinois

Job Description


Target PR Range: 29-39/hr
*Depending on experience

Job Description :
Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.?
Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
Monitoring of safety-related queries to Investigators.
Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
Current with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance.
Qualifications:
Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.
Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
Ability to present accurate and medically sound safety data, both orally and in writing.
Effective communication skills in delivering study-related information.
Proficiency in Computers (Windows, Word, Excel).

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.

*CO/NYC candidates might not be considered

Job Tags

Remote job, Contract work,

Similar Jobs

Testa Produce

Order Selector Job at Testa Produce

Founded in 1991, Testa Produce, Inc. is the successor entity to the original Dominick Testa and Sons. The members of the Testa Family own Testa Produce, Inc. with the controlling interest currently held by Peter Testa. Testa Produce's roots date back to 1912, with founder...

Mark Young Construction

Construction Laborer (Must be able to work Days & Nights) Job at Mark Young Construction

 ...Construction, LLC (MYC) has an excellent opportunity for Construction Laborers to join us as we continue to grow! Construction Laborers/...  ...throughout the year. ***Must be able to work both day and night shifts*** Essential Duties and Responsibilities:... 

Bright Horizons Family Solutions

Temporary Child Care Instructional Coach , Brooklyn Job at Bright Horizons Family Solutions

 ...Join our team as an Early Childhood Instructional Coach and empower teachers to succeed with the resources, support, and professional development they need. Your expertise in child development and early education will inspire and motivate your team to excel in the classroom... 

Serenity Mental Health Centers

Patient Care Advocate Job at Serenity Mental Health Centers

 ...clinical side you bring the empathy, energy, and commitment to making every patient feel seen and supported. The Role: Patient Care Advocate | Desert Ridge, AZ In this role on our clinical support staff, youll listen and help guide patients, educate and encourage... 

Supergut

Social Media Manager Job at Supergut

 ...health and wellness brand, were building community through meaningful experiences, operational excellence, and culture-shaping storytelling. About the Role Were seeking a Social Media Manager to take the reins of our social media presence and bring our brand...