What does a Drug Safety Physician do?

Explore the responsibilities, collaboration, and growth opportunities of a Drug Safety Physician in the Clinical Research Industry

Drug Safety Physicians play a crucial role in ensuring patient safety and regulatory compliance in clinical research. At Parexel, these professionals contribute to the development of safe and effective medications by monitoring, analyzing, and reporting on drug safety data. Their expertise supports Parexel's mission to deliver innovative healthcare solutions while maintaining the highest standards of patient protection.

Browse our open Drug Safety Physician positions or learn more about a day in the life of a Drug Safety Physician.

Q: What are the job responsibilities of a Drug Safety Physician?

A: Drug Safety Physician at Parexel has diverse responsibilities, including:

• Performing medical and safety monitoring activities for assigned projects

• Conducting medical reviews of adverse event reports and case narratives
• Contributing to periodic safety reports such as PBRERs, PSURs, and DSURs
• Providing medical expertise for signal detection and management
• Collaborating on risk management plans and safety surveillance strategies
• Offering medical guidance to pharmacovigilance teams and study teams
• Reviewing and authoring key regulatory documents
• Participating in client and cross-functional meetings

Q: What career progression is typical for a Drug Safety Physician?

A: Career progression for a Drug Safety Physician at Parexel may include:

• Starting as an entry-level Drug Safety Physician
• Advancing to a Senior Drug Safety Physician role & Principal Drug Safety Physician role
• Specializing in specific therapeutic areas or types of safety reporting
• Moving into a Brand Safety Physician position
• Taking on leadership roles within the Global Safety Services department
• Transitioning to broader roles in Medical Affairs or Clinical Development
• Advancing to managerial positions overseeing safety teams
• Becoming a subject matter expert in pharmacovigilance and drug safety

Q: Which roles do I collaborate with as a Drug Safety Physician?

A: As a Drug Safety Physician, you'll collaborate with various internal and external stakeholders, including:

• Pharmacovigilance and safety teams
• Clinical research associates and project managers
• Medical writers and data management professionals
• Regulatory affairs specialists
• Clients and sponsors
• Investigators and study coordinators at clinical sites
• Health authorities and regulatory bodies
• Cross-functional teams within Parexel, such as Clinical Operations and Biostatistics

Q: How does a Drug Safety Physician in clinical research & pharmacovigilance differ from other industries?

A: Drug Safety Physician in clinical research & pharmacovigilance differs from those in other industries in several ways:

• Primary Focus on Drug Safety: Continuous monitoring, assessment, and reporting of adverse events in both clinical trials and post-marketing settings.
• Regulatory Compliance: Adherence to global pharmacovigilance guidelines (e.g., ICH, EMA, FDA) and timely safety reporting.
• Signal Detection & Risk Management: Identification of emerging safety signals, benefit-risk evaluations, and contributions to Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs).
• Lifecycle Safety Oversight: Involvement from early drug development through post-approval to ensure consistent safety strategy.
• Data-Driven Decision Making: Use of structured safety data, aggregate analyses, and medical review of individual case safety reports (ICSRs).
• Cross-Functional Collaboration: Engagement with safety operations, regulatory affairs, medical writing, and clinical teams.
• Global Exposure: Participation in international programs and interactions with global health authorities across diverse therapeutic areas.
• Involvement in Drug Development: Active role in early-phase clinical trials and investigational drug safety.
• Regulatory Submissions: Contribution to the preparation of safety sections in regulatory submissions for new drugs.
• Knowledge of Clinical Protocols: Requirement for deep understanding of clinical trial protocols and Good Clinical Practice (GCP) guidelines.
• Stakeholder Engagement: Collaboration with a broad range of stakeholders throughout the drug development lifecycle.
• Innovation and Novel Therapies: Opportunities to work on cutting-edge treatments and innovative therapeutic approaches.

Q: Will I have to travel as a Drug Safety Physician?

A: While travel requirements can vary depending on specific project needs and your role within the organization, Drug Safety Physicians at Parexel generally have limited travel obligations. Most of your work can be performed remotely or from your assigned office location. However, occasional travel may be required for:

• Attending investigator meetings or site initiations
• Participating in client meetings or regulatory authority interactions
• Presenting at conferences or industry events
• Collaborating with cross-functional teams at different Parexel locations
• Attending internal training sessions or company-wide meetings

Q: Are there remote job opportunities as a Drug Safety Physician?

A: Yes, Parexel offers remote job opportunities for Drug Safety Physicians. Remote opportunities allow Drug Safety Physicians to:

• Work from home or any suitable location with internet access
• Collaborate virtually with global teams using digital communication tools
• Maintain a better work-life balance
• Access a wider range of job opportunities regardless of geographical location
• Contribute to Parexel's global projects from anywhere in the world