Lead Patient Safety Strategy for Global Brands
Parexel is a leading global clinical research organization (CRO) dedicated to advancing medical breakthroughs. We are seeking an experienced Senior Patient Safety Physician to provide expert medical safety oversight for designated products. In this pivotal remote role, you will act as the Subject Matter Expert (SME), performing complex medical reviews, guiding risk management strategy, and mentoring junior team members. Your expertise will ensure the robust safety monitoring and regulatory compliance of critical therapies.
Your Key Responsibilities
Core Safety Surveillance & Case Management:
- Perform in-depth medical review of complex individual case safety reports (ICSRs), including clinical trial, post-marketing, and literature cases, assessing causality, seriousness, and expectedness.
- Provide medical inputs and guidance to case processing teams, ensuring medical coherence in narratives and regulatory responses.
- Write Marketing Authorization Holder (MAH) comments and provide expert medical judgment for challenging cases.
Risk Management & Strategic Planning:
- Contribute to Pharmacovigilance and Risk Management planning, preparing safety surveillance strategies and tracking potential safety issues for assigned products.
- Support the preparation, maintenance, and update of Risk Management Plans (RMPs) and the safety sections of the Company Core Data Sheet (CCDS) and labeling.
- Conduct and support signal detection, evaluation, and safety assessments (e.g., Safety Evaluation Reports), including product quality issues.
Regulatory Documentation & Submissions:
- Prepare and review periodic safety reports (PBRER/PSUR, DSUR, Renewals) in accordance with global regulatory requirements.
- Provide safety content review for clinical protocols, study reports, Investigator Brochures (IBs), and other key documents.
- Contribute to regulatory submissions (IND, NDA, MAA) by reviewing safety data and preparing relevant filing documents.
Leadership & Collaboration:
- Act as a Subject Matter Expert and mentor for junior team members.
- Coordinate safety activities between the Drug Safety team and internal/external partners.
- Provide input for Drug Safety Monitoring Boards (DSMBs) or independent monitoring committees as required.
- Perform literature surveillance and epidemiological research to support safety assessments.
Your Profile: Qualifications & Experience
Required:
- Medical degree (MD or equivalent) with a valid license to practice.
- Significant, hands-on experience in Pharmacovigilance / Drug Safety within a pharmaceutical company or CRO.
- Proven expertise in medical review of ICSRs, signal detection, and risk management.
- In-depth knowledge of global pharmacovigilance regulations (ICH E2, FDA, EMA) and experience authoring PBRERs, RMPs, and DSURs.
- Experience contributing to regulatory submissions and reviewing clinical documents.
- Excellent analytical, communication, and leadership skills.
Preferred:
- Specialty training or significant experience in a specific therapeutic area relevant to the assigned products.
- Experience with drug-device combination products.
- A track record of successfully mentoring junior physicians or scientists.
Why Join Parexel?
- Global Impact: Provide expert safety oversight for therapies that impact patients worldwide.
- Strategic Leadership Role: Act as the medical safety authority for assigned brands, shaping strategy and guiding teams.
- Remote Flexibility: Work from anywhere while collaborating with a global team of experts.
- Career Growth: Develop your expertise as a senior physician in a leading global CRO with a clear path for advancement.
Ready to be the medical safety leader for critical pharmaceutical brands?
Apply now for the Senior Patient Safety Physician position.
Parexel is an equal opportunity employer. We welcome applications from all qualified individuals.
