Medical Safety Director

Position: Medical Safety Director )
Join our dynamic Patient Safety team as a Medical Safety Director where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post‑marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.
About

The Role  As a Medical Safety Director, you will serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You will collaborate with cross‑functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.
Key Accountabilities    General   Maintain a working knowledge of the adverse event/safety profile of assigned products, labeling documents, data handling conventions, client guidelines and procedures, and global drug safety regulations and guidelines.
Stay aware of global regulatory requirements, reporting obligations, and organize workload to meet internal and regulatory timelines for adverse event reporting.
Communicate and discuss issues related to the review process with Line Manager, Project Leader, and Designee.
Interact with internal and external stakeholders to resolve issues.
Attend and/or present at client/cross‑functional meetings, acting as a subject matter expert.
Assist the Project Lead/Functional Lead for audits and inspections.
Provide inputs for process improvements and KPI achievement.
Act as pharmacovigilance representative/safety scientist.
Attend/support bid defense meetings.
Mentor Patient Safety Physicians and develop their skills.

Case Report Medical Review   Perform medical review of cases (including complex and challenging cases requiring expert judgement) in clinical trials and literature.
Write pharmacovigilance/MAH comments and assess causality.
Review medical content in narratives for coherence and seriousness.
Provide medical inputs to the case processing team.
Raise follow‑up queries for reporter/HCP information.
Verify selection of adverse events, assign MedDRA codes, and review narratives.
Identify and resolve case issues in coordination with client therapeutic/legal teams.
Guide junior physicians on case assessment methodologies.

Periodic Reports   Review or author aggregate reports for medical content and consistency per client SOPs.
Provide medical input for preparatory documents such as PBRERs, PSURs, SERs, HA responses, DSURs, COs, ACOs, HHEs, and other regulatory reports.
Review reports assessed by junior team members for accuracy and completeness.

Medical Monitoring   Answer day‑to‑day medical and scientific questions, providing support to Parexel staff or study sites.
Review and sign off adverse event reports for accuracy, severity, and study drug relationship.
Provide periodic experience reports to sponsors and authorities.
Present material at internal and external meetings, including investigator meetings and therapeutic area training.
Review data management line listings, identify clinically meaningful trends, and follow up as necessary.
Review and sign off technical documents with a focus on patient safety.
Review coding of adverse events, medical history, and concomitant medications for consistency.
Provide support for clinical protocol preparation and other client documents.

Literature Review   Review literature for product safety assessment and potential safety issues.
Triage, summarize, and provide MAH comments for aggregate reports and signal management activities.

CSR Narratives   Perform medical review of clinical study report narratives per client guidelines and SOPs.

Medical Guidance to PV Team/Study Team   Provide guidance during the case processing cycle.
Offer input to Feasibility Studies, DMCs, and CECs.
Support mentoring or training of newly hired physicians as needed.

Signal Detection and Management   Perform signal detection and validation activities per client conventions/SOPs.
Author or review SERs and…