Serm Associate Medical Director

3 giorni fa


Siena, Italia Glaxosmithkline A tempo pieno

Site Name: Italy - Siena
Posted Date: Aug 9 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
The SERM, Associate Medical Director will provide medical and scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
He/She will ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. The SERM, Associate Medical Director will make recommendations for the further characterization, management, and communication of safety risks.
The SERM, Associate Medical Director will also focus on efficiency and effectiveness to meet the needs of our Patients and HCPs, supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
In this role you will…Responsible for signal detection and evaluation activities for assigned products.Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).Authors the SERM safety contribution to global regulatory submissions.Supports and facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.Presents complex issues to senior staff members at the GSK Senior Governance Committees.Why you?Qualifications & Skills: Medical Doctor (physician), with additional relevant medical or scientific post-graduate qualifications.Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.Closing Date for Applications – September 15th, 2024 Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
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