Join our dynamic Patient Safety team as a Senior Physician 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 Senior Physician in Patient Safety , 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 (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 required
Review reports assessed by junior team members for accuracy and completeness
Medical monitoring (as applicable)
Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed
Review 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 authorities
Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
Provide medical safety expertise to client per request
Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities
Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety
Review coding of adverse events, medical history and concomitant medications for accuracy and consistency
Review of patient profile report as needed
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other Parexel departments
Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings)
Literature review (as applicable)
Review of literature for product safety assessment and potential safety issues
Expert in reviewing literature references including triaging, summarizing and providing MAH comments for aggregate reports and for various signal management activities
CSR Narratives (as applicable)
- Performing medical review of Clinical study report narratives according to the client's guidelines and SOPs
Provide medical guidance to PV team/study team
Provide medical guidance to safety staff during the case processing cycle
Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs)
Provide medical input into Pharmacovigilance workflows and projects as required
On an as-needed basis, provide support in mentoring or training of new hired physicians
Signal Detection and Management (as applicable)
Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities
Perform signal validation activities
Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness
Author/review responses to HA requests and other safety documents
Providing oversight and relevant inputs to Medical Writers (MWs) authoring SERs, Signal validations etc.
Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)
Contribution to Safety Management Team (SMT) meetings: Data analysis/ review, content creation, presentation/ facilitation, drafting of meeting minutes
Training and mentoring junior team members on signal detection methodologies
Brand safety Physicians (as applicable)
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues
Support the preparation and maintenance of Risk Management Plans
Prepare and review periodic sa
