Medical Reviewer

Planet Pharma; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma is seeking a nurse with 2+ years bedside experience transitioning into the pharma industry. The role involves clinical safety data review, adverse event reporting, and ensuring regulatory compliance across multiple studies.

Responsibilities include CRF review, data QA, and collaboration with Medical Affairs, Clinical, and Regulatory teams. Strong communication and data interpretation skills are essential for success in this position.

Qualifications

• Minimum 2 years of clinical practice required.
• 1 year drug safety experience preferred.
• Bachelor's degree in health sciences; RN or pharmacy experience preferred.
• Strong critical thinking and data interpretation skills.
• Excellent written and verbal communication.

Responsibilities

• Perform in-house review of Case Report Forms (CRFs) including query resolution and QA of data listings.
• Investigate and report adverse events for FDA filings; support safety data package preparation.
• Provide medical support to Medical Affairs, Clinical, and Regulatory teams.
• May train internal staff and investigator meetings on safety issues.
• Manage files and budgets across multiple clinical studies; oversee regional CRAs as needed.

Skills

Critical thinking

Medical data review

Safety data analysis

Written and verbal communication

Microsoft Office

Education

Bachelor's degree in health sciences

RN or clinical pharmacy experience

Tools

CRF review tools

FDA regulatory databases

Job description

Looking for a nurse with 2+ years of bedside experience looking to make the transition into the pharma industry.

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.

Experience/Skills

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.