Senior Aggregate Report Specialist PSS

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Job description

Job Overview:Labcorp Drug Development are hiring a Senior Aggregate Report Specialist PSS to join our team in Edinburgh, candidates can be based anywhere in the UK.Role responsibilities:> Generation of DSUR or other periodic report timelines/project plan, share withstakeholders and reviewers (and client) for agreement on review timelines> If applicable, arrange DSUR/ Periodic reports kick off meeting with required participantsand DSUR stakeholders> Ensuring critical resources are available during the process (i.e. Submissions team,Publishing services, etc.)> Coordinating efforts from multiple parties involved with the periodic report/ DSURprocess (including internal groups and clients) to ensure responsibilities are clearly definedand the DSUR project plan is successfully implemented within projected timelines> Communicating critical updates to internal and client teams and addressing questions asneeded> Actively participating in routine internal team and client meetings> Facilitating the collection of study data from multiple parties (i.e. Data Management,Biostatistics, Clinical, client teams, etc.) within projected timelines> Performing literature searches to ensure all critical safety and efficacy data is included inthe DSUR or other applicable periodic reports> Requesting feedback from clients regarding report content and style preferences (stylepreference needs to be asserted before drafting starts)> Coordinating and overseeing publishing services by Medical Writing team> Drafting and finalizing DSUR or other periodic reports within projected timelines> Ensuring timely provision of finalized fully executed report to client and Submissions teamin order to successfiiliy meet submission deadlines> Reviewing and providing editing recommendations/guidance for DSURs / periodic reportsdrafted by other team members.> Organize generation of line listings and other data sources for periodic reporting.> Work with project teams to coordinate the activities around data lock point and generationof data from safety database.> May execute routine quality review of AE reports and aggregate reports for other membersof the group ensuring that case processing and data quality meet global regulatorycompliance needs including audit support.> Maintain a strong understanding of Covance's safety database conventions or clientspecificdatabase conventions, as appropriate.> Begin to participate and demonstrate leadership on projects which enhance team and/ordivision performance. This includes acting as a lead contact for projects including globalprojects ensuring communication and process harmonization.> Assist in the development of departmental Work Instructions (WI) and Standard OperatingProcedures (SOPs), as appropriate.> Ensure compliant safety reporting in accordance with global reporting regulations, SOPsand safety processing guidelines set forth by departmental management team and theclient,> Participate in the generation of monthly status and other project-specific reports ensuringthe quality and accuracy of metrics/data are provided.> Responsible for making decisions regarding periodic reports within the guidelines of eachspecific project.> Assist DDSS management to identity out of scope work.> Actively participates in project team and client meetings and liaise with clients, whereappropriate.> Prepare and/or participate in client or regulatory audits.> Any other duties as assigned by management.#LI-NC1 EMEAEducation/Qualifications:Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy,Nursing, Life Sciences, and Chemistry.At least one year experience in writing of DSURs or other periodic reports/ aggregate reports isrequired.Safety experience includes actual experience processing AE/SAE reports, generating narratives,queries, working within safety databases, and experience with regulatory submissions.Experience:Required:Good verbal, written and presentation skills.Must be able to communicate effectively in the English language.Ability to interact and influence with line and middle management, staff and external contacts on afunctional and tactical level.High degree of accuracy with attention to detail.Functions as a team player.Ability to present and share useful business information across departments and functions.Ability to anticipate and identify problems and take appropriate action to correct.Knowledge of medical and drug terminologyKnowledge of Good Clinical Practice (GCP) related to clinical safety documentationKnowledge of ICH GuidelinesKnowledge of Medical Device reporting desirableKnowledge of worldwide regulatory requirements and reporting of adverse event for bothmarketed and investigational products.Good knowledge and understanding of industry and R&D processes and objectives.Ability to work independently with minimal supervisionGood keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.