Drug Safety Physician

Job Description

JOB DESCRIPTIONBusiness Card Job TitleDrug Safety PhysicianJob Code436DepartmentFunctional Service Provider (Safety Services)SBUMedical Safety Services (MSS)LocationGlobalReports ToDepartmental Line Manager, Medical Safety ServicesDirectly SupervisesNoneProvides Work Direction toPV Operations StaffWorks Closely withPV Operations staffExternal RelationshipsClients and relevant stakeholdersBillable Job Yes No If billable part-time, select yesSelect One Individual Contributor People ManagerPurpose: 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 Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Provide medical advice/input for narratives written for Clinical Study Reports (CSRs) Provide medical, safety input and review of all required safety reports, such as- but not limited to - Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/ Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification letters Function as pharmacovigilance representative/safety scientistKey Accountabilities:AccountabilitySupporting ActivitiesGeneral Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholdersCase report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing teamPeriodic reports (as applicable) Review and authoring of aggregate reports for medical context and consistency in accordance with client requirements and SOPs Providing medical advice to case processors for authoring of sectionsLiterature review (as applicable) Review of literature for product safety assessment and potential safety issuesCSR Narratives (as applicable) Performing medical review of CSR narratives according to the client s guidelines and SOPsSafety Scientist (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 plansQualificationsSkills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVPKnowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: Graduation/Post Graduation in Medicine.,

Keyskills :
medical reviewstudy reportscompliancestandard operating procedurescasegvpdrug safetyrisk assessmentmusic makingrisk management plansproduct safetysafetyrisk management