Serm Associate Scientific Director

3 mesi fa

Siena, Italia GSK A tempo pieno

**Site Name**: UK - London - New Oxford Street, Canada - Ontario - Mississauga, Italy - Siena, Poznan Grunwaldzka, Warsaw Rzymowskiego 53
**Posted Date**: Sep 25 2024

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.

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.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

**In this role you will be part of a team supporting**:

- Responsible for signal detection and evaluation activities for assigned products
- 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.
- Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
- Support safety governance/Safety Review Teams in 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.
- Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds appropriately to the views and feedback of others.

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

- Experience in early clinical development
- Experience working in large matrix organizations
- Experience working globally in pharmacovigilance or drug development
- IT competencies - prior experience with data visualisation tools (e.g. Spotfire, Clinical Cockpit), Argus Safety, CVW, Power BI reporting would be beneficial.

**Closing Date for Applications - 09 Oct 2024 (COB).**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

Find out more:
Our approach to R&D.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of peo

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