Medical Safety Reviewer

ICONMA; Thousand Oaks (CA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Medical Safety Reviewer to ensure the quality of medical reports and compliance with regulatory standards. The role involves executing medical reviews, conducting assessments for drug safety, and participating in cross-functional initiatives. Candidates should possess a Clinical Nursing qualification and ideally have experience in drug safety.

Benefits

Health Benefits

Referral Program

Excellent growth and advancement opportunities

Qualifications

• At least 3 years of drug safety experience required.
• Clinical Nursing qualification with 5 years of relevant work experience preferred.

Responsibilities

• Execute the medical review of ICSRs to ensure quality reports.
• Support quality assurance of ICSR medical review.
• Conduct reportability assessments for medical device-associated events.

Skills

Knowledge of client Case Management and medical review SOPs

Clinical knowledge of therapeutic area patient populations

Proficiency in technical safety systems

Knowledge of safety data capture

Knowledge of clinical trials and drug development processes

Understanding of client products and patient populations

Education

Clinical Nursing qualification

Nursing Degree

Job description

Our Client, a Biopharmaceutical company, is looking for a Medical Safety Reviewer for their Thousand Oaks, CA/Remote location.

Responsibilities:

1. Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports.
2. Act as MSRT product lead as assigned.
3. Execute ICSR case escalation as appropriate.
4. Execute appropriate case follow-up per SOPs.
5. Support medical coding conventions and systematic process improvements for ICSR medical review.
6. Maintain list of expected terms in the auto label tool.
7. Support Quality Assurance of ICSR medical review.
8. Participate in Safety Assessment Team (SAT) meetings, if applicable.
9. Conduct reportability assessments for medical device-associated events and product complaints, reviewing for potential product problems.
10. Provide input on teams for interdepartmental and cross-functional initiatives, if applicable.
11. Perform other duties related to the position as necessary, as defined in SOPs or as requested by supervisor.
12. Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness.
13. Serve as a point of contact for Health Authority Inspections and Internal Process Audits within the role's remit.

Requirements:

1. Knowledge of client Case Management and medical review SOPs and regulatory requirements for pharmacovigilance.
2. Clinical knowledge of therapeutic area patient populations and drug classes.
3. Proficiency in technical safety systems including Safety Database and medical coding.
4. Knowledge of safety data capture in Clinical Trials and Post Marketing settings.
5. Knowledge of clinical trials and drug development processes.
6. Understanding of client products and patient populations (preferred).
7. Clinical Nursing qualification and at least 3 years of related drug safety experience.
8. Medical Qualification (Nursing Degree) plus 5 years of relevant work experience.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an environment that supports and encourages all individuals regardless of race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by law.