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'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:

General

• Maintaining 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 guidelines

• Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

• Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee

• Interacting with internal and external stakeholders for resolving issues

• Attending 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 inspections

• Provides inputs for process improvements

• Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process

• Function as pharmacovigilance representative/safety scientist

• Attend/support Bid defense meetings

• Actively mentoring Patient Safety Physicians to develop their skills and expertise

Case 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 require

• Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality

• Review appropriateness of medical content in narrative for medical coherence

• Assessing seriousness, listedness / expectedness of reported events.

• Providing medical inputs to case processing team

• Raising 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 narrative

• Identify and resolve case issues, coordinate with client therapeutic/legal team

• Provide guidance to junior physicians on case assessment methodologies

Periodic reports (as applicable)

• Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs

• Providing 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