Medical Monitor - Rheumatology (Contract)

Job title: Medical Monitor - Rheumatology (Contract)

We are seeking a Medical Monitor for a contract role to provide medical oversight of clinical trials, ensure compliance with company SOPs, client directives, ICH/GCP, and regulatory requirements. The role includes attending investigator and sponsor meetings, providing medical consultation, supporting business development activities, and conducting medical reviews of safety and regulatory deliverables.

What You'll Do

• Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

• General Support:

• Ensure tasks delegated to PVG are properly executed and compliant with regulations, ICH guidelines, client SOPs/directives, and project WPDs.

• Provide medical consultation to team members and clients; maintain clear communication to ensure procedures are followed.

• Provide therapeutic and protocol training on assigned studies.

• Assist in writing/review of CSR, IND/NDA reports, ICSR, signal detection reports, periodic safety reports (e.g. PBRER, PSUR, DSUR), as well as CTD modules, REMS, RMP, and CSR documents.

• Clinical Trial Support:

• Monitor safety variables (AEs, lab abnormalities, patient status changes, concomitant medications) and protocol restrictions.

• Discuss medical concerns with principal investigators and clients; apply medical judgment to clinical scenarios.

• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes.

• Perform data review as per contract and data validation manual to identify potential safety concerns.

• Marketed Products Support:

• Manage signal detection activities; review aggregate reports; contribute to label updates; support dossier maintenance and risk management.

• Medically review adverse event data from all sources (solicited, spontaneous, literature, etc.).

• What We're Looking For

• Education and Experience:

• MD board certified in Rheumatology.

• Either clinical experience in Rheumatology (comparable to 2 years), or suitable clinical trial experience in CRO/pharma/PI role (comparable to 1-2 years), or direct safety/pharmacovigilance experience (comparable to 2 years).

• In some cases, an equivalency consisting of a combination of appropriate education, training and/or related experience may be considered.

• Knowledge, Skills and Abilities:

• Therapeutic expertise in Rheumatology.

• Strong decision-making, problem solving, organizational and analytical skills.

• Excellent oral and written communication.

• Working knowledge of safety databases (MedDRA).

• Flexibility to travel domestically and internationally.

• Ability to work independently and manage sensitive, complex information with attention to detail.

• Proficiency in basic computer applications.

• Fluent in English (spoken and written).

• Excellent interpersonal, influencing and team-building skills.

• Understanding of FDA/ICH/EMA and GCP guidelines.

• Working knowledge of biostatistics, data management, and clinical operations procedures.

• Ability to mentor/train other staff.

• Compensation & Benefits

• Pay Rate Range: $150-$170 per hour (USD).