Prinicpal Drug Safety Physician

Job Description

Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Ongoing safety surveillance and signal detection/analysis Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety Provide medical input in all required safety reports, such as but not limited to PSURs, Clinical Expert Statement, Investigator notification letters Review all documents assigned for scientifically relevant issues including drug safety Function as Pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings Provide medical advice and support for the safety component of feasibility studies Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products Support of Medical Directors as required Support of the QPPV Provide medical monitoring for assigned projects Review all documents assigned for scientifically/medically relevant issues including drug safety Function as medical representative/technical lead/senior technical lead on the projects, in Proposal Development Team and/or client meetings Provide advice and support for feasibility studies Provide support for DMC and CEC managementRelationshipsReports To Regional Head of Medical Sciences/ Medical Sciences Line ManagerDirectly Supervises NoneProvides Work Direction to Drug Safety staffWorks Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations GroupExternal Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics CommitteesKey Accountabilities Medical and scientific Pharmacovigilance review of:o Literature Reports including epidemiological background researcho Clinical trial reportso Study protocolso Clinical Trial (Serious) Adverse Event Reportso Post-marketing ADR reportso Case files, narratives, coding, causality and expectedness assessment Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support Provide medical guidance to Safety Staff during the case processing cycle Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings) Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs). Participate in Proposal Development Teams (PDTs) for client bid meetings Provide support for marketing activities as requested Provide medical safety expertise to client per request Medical monitoring answering day to day medical and scientific questions, provide dailyQualificationsSkills Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications Computer skills Good knowledge of drug safety and the drug development process Good presentation skills Good interpersonal skills Good verbal / written communication skills Good time management skills Client focused approach to workEducation Physician Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.); or comparable post-graduate experience in clinical research, Pharmacovigilance or regulatory domain.Language Skills Fluent English,

Keyskills :
drug safetysafetycasecompliancegvpmedical reviewmedical writingrisk assessmenttime managementcase processingdata monitoring