On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Medical Information & Compliance Executive.
This is a hybrid role with 3 days a week in the office.
Purpose and Scope The purpose of this role is to ensure legislative, IPHA code, Internal Code of Conduct & Quality norm compliance across designated business critical systems.
Key Responsibilities Act as first line contact for Medical Information EnquiriesEnsure compliance with all product safety, regulatory affairs and pharmacovigilance requirementEnsure key Quality records are maintained in accordance with SOPsParticipate in conducting internal audits as requiredDevelop processes / author SOPs as requiredKey Tasks Ensure that the reconciliation between Medical Information function and Pharmacovigilance and Quality department is effective by performing ad-hoc review on reconciliation filesMaintain key Quality process records for Training, Product complaints, SmPC/API updates and Medical InformationCollaborate with Quality & Compliance Manager to perform internal audit checks on other processes as required.Receipt, correct documentation and follow-up as appropriate of all Medical Information Enquiries and Product ComplaintsLiaise with Medical Information Service Provider and Medical Advisors/Head of Medical Affairs as appropriateDissemination and implementation of updates to SmPCs, APIs and PILsReporting of adverse events to drug safety unit ManagerManage internal process for implementation of variationsLiaise with relevant internal and external stakeholders regarding product shortagesContribute to development of company SOPs as required.Actively participate as part of the Quality team, ensuring a Quality mindset is applied to all internal processes and documentation in order to ensure demonstrable due diligence.Ensure all process documentation is maintained consistently and adequately for internal or external audit purposes.
Ensure follow up corrective actions for findings if any.Assist in preparation of training materialsAssist in dissemination and recording of trainingCreation and roll-out of training courses to staff on the internal learning platform.Candidate Requirements Post graduate degree in Life Sciences or pharmacyHighly organised and detail orientedExcellent communication and problem solving skills2 years' experience in the pharmaceutical industry preferably in pharmacovigilance, medical information/ medical affairsStrong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrityFor full job spec and information please send your CV to ****** or call Linda at 01 2784703.
Thornshaw Scientific is a division of the CPL Group of companies.
#LI-LD1
#J-18808-Ljbffr