Medical Safety Director

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.External Job DescriptionJoin 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 RoleAs a Medical Safety Director, you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross-functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.Key Accountabilities:GeneralMaintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelinesMaintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reportingCommunicating and discussing issues related to review process with Line Manager/ Project Leader/DesigneeInteracting with internal and external stakeholders for resolving issuesAttending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)Assisting the Project Lead/Functional Lead for audits and inspectionsProvides inputs for process improvementsWorks closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the processFunction as pharmacovigilance representative/safety scientistAttend/support Bid defense meetingsActively mentoring Patient Safety Physicians to develop their skills and expertiseCase report medical review (as applicable)Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as requireWriting Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causalityReview appropriateness of medical content in narrative for medical coherenceAssessing seriousness, listedness / expectedness of reported events.Providing medical inputs to case processing teamRaising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrativeIdentify and resolve case issues, coordinate with client therapeutic/legal teamProvide guidance to junior physicians on case assessment methodologiesPeriodic reports (as applicable)Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPsProviding medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc.Clinical Expert Statements and other documents as requiredReview reports assessed by junior team members for accuracy and completenessMedical monitoring (as applicable)Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as neededReview and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authoritiesAttend and present material (such as therapeutic area training), as requested,