Senior Physician, Patient Safety

Medical ReviewerMedical ReviewerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

6 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior Physician, Patient Safety

Parexel

Role Description 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. Qualifications - Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD) - 2+ years of experience in ICSR Medical Review - Completion of at least basic training in clinical medicine (residency, internship etc.) - Good knowledge/understanding of medical terminology - Relevant experience in pharmacovigilance/Drug Safety/Clinical Practice Requirements - 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 - Providing inputs for process improvements - Working closely with Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs) for the process - Functioning as pharmacovigilance representative/safety scientist - Attending/supporting 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 required - Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality - Reviewing 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) - Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, reviewing narrative - Identifying and resolving case issues, coordinating with client therapeutic/legal team - Providing guidance to junior physicians on case assessment methodologies Knowledge and Experience - Experience in pharmacovigilance and medical monitoring activities desirable but not essential Education - Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD) / Medically qualified from an acknowledged Medical School

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