Senior Physician, Patient Safety

Job details

Key Requirements:

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):

Perform medical review of cases, including complex and challenging cases requiring expert judgment, covering clinical trial, literature, and combination product (drug-device) cases according to client/Parexel Standard Operating Procedures and liaising with the client, as required.

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

Knowledge & Experience:

#LI-REMOTE