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 Enquiries Ensure compliance with all product safety, regulatory affairs and pharmacovigilance requirement Ensure key Quality records are maintained in accordance with SOPs Participate in conducting internal audits as required Develop processes / author SOPs as required Key Tasks Ensure that the reconciliation between Medical Information function and Pharmacovigilance and Quality department is effective by performing ad-hoc review on reconciliation files Maintain key Quality process records for Training, Product complaints, SmPC/API updates and Medical Information Collaborate 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 Complaints Liaise with Medical Information Service Provider and Medical Advisors/Head of Medical Affairs as appropriate Dissemination and implementation of updates to SmPCs, APIs and PILs Reporting of adverse events to drug safety unit Manager Manage internal process for implementation of variations Liase with relevant internal and external stakeholders regarding product shortages Contribute 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 materials Assist in dissemination and recording of training Creation and roll-out of training courses to staff on the internal learning platform, Candidate Requirements Post graduate degree in Life Sciences or pharmacy Highly organised and detail orientted Excellent communication and problem solving skills 2 years' experience in the pharmaceutical industry preferably in pharmacovigilance, medical information/ medical affairs Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity For full job spec and information please send your CV to ****** or call Linda at 01 2784703.