Medical Information & Compliance Executive

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 oriented

· 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 [email protected] or call Linda at 01 2784703. Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com

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