SERM Associate Scientific Director

As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.

You 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. As SERM Associate Scientific Director you will focus on efficiency and effectiveness to meet the needs of our Patients and Regulatory Authorities. You will be part of a team of physicians and scientists 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 be part of a team supporting:

• Production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines; advise on content of regulatory period reports.
• SERM safety contribution to global regulatory submissions, including RMPs.
• Safety governance/SRTs in the clinical development and post marketing settings to detect and address product safety issues.
• Ensuring risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Making recommendations for the further characterization, management, and communication of safety risks.
• Presenting complex issues to senior staff members at the GSK Senior Governance Committees.

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Substantial experience in pharmacovigilance or drug development.
• Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Ability to function successfully in cross-functional groups

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Experience working in large matrix organizations
• Experience working globally in pharmacovigilance or drug development
• IT competencies

Closing Date for Applications - 25 Oct 2024 (COB)

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. The information that you have provided in your cover letter and CV will be used to assess your application.