Serm Associate Scientific Director

Il y a 3 mois

Wavre, Belgique GSK Temps plein

**Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga
**Posted Date**: Sep 3 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**:

- 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 - 17 Sep 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 people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can b

  • Serm Associate Scientific Director

    Il y a 2 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga **Posted Date**: Oct 11 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...

  • Serm Senior Scientific Director, Oncology

    il y a 4 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - Brentford, Belgium-Wavre **Posted Date**: Nov 15 2024 **Job Purpose**: Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business...

  • Serm Associate Medical Director

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga **Posted Date**: Sep 3 2024 As SERM Associate Medical Director you will provide medical 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...

  • Serm Scientific Director

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre **Posted Date**: Sep 23 2024 **Job Description**: **Job Purpose**: Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of...

  • Serm Scientific Director, Oncology

    il y a 4 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre **Posted Date**: Nov 15 2024 Are you energized by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this Safety Pharmacovigilance Director role could be an ideal opportunity to explore. As a...

  • Serm Medical Director, Oncology

    il y a 4 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre **Posted Date**: Nov 15 2024 **Job Purpose**: Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management...

  • Safety, Evaluation

    il y a 4 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Nov 19 2024 **Job purpose**: Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues...

  • Associate Director, Global Real-world Evidence

    Il y a 2 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, UK - London - New Oxford Street, USA - Maryland - Rockville **Posted Date**: Oct 8 2024 Established as a focused global function**, Data Generation & Scientific Communications**, is uniquely placed to help accelerate the successful integration of our medicines and vaccines...

  • Medical Scientific Liaison Hematology

    il y a 2 semaines

    Wavre, Belgique AbbVie Temps plein

    **Company Description** **Job Description** Job purpose & objectives**: The **field**-based role focuses on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and providers). The focus of this role is on **interacting** with, and supporting the needs of, **Tiered External Experts in...

  • Global Clinical Development Associate Director

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw **Posted Date**: Sep 23 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive...

  • Director Scientific

    il y a 4 semaines

    Wavre, Belgique SGS Temps plein

    Job Description GLOBAL SCIENTIFIC & TECHNICAL CAPABILITY EXCELLENCE Global Expert position overseeing the Health Science laboratory service portfolio globally (including chemistry, microbiology, protein characterization, biosafety, and bioanalysis – for both small and large molecules) to ensure that scientific and technical capabilities are...

  • Safety Evaluation

    Il y a 4 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre, UK - London - New Oxford Street **Posted Date**: Aug 21 2024 **About the role**: As Safety Evaluation and Risk Management Principal (SERM) Scientist, you provide medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting. You ensure...

  • Associate Director; Pharmacovigilance Agreements

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 12 2024 As Associate Director, Pharmacovigilance Agreements & Safety Clauses (PVASC) you will support Pharmacovigilance Operations (PV Ops) in in alignment with GSK standards and regulatory timelines whilst driving the implementation of...

  • Director Scientific

    il y a 7 jours

    Wavre, Belgique SGS Temps plein

    **Company Description** We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world. **Job Description** GLOBAL SCIENTIFIC & TECHNICAL CAPABILITY EXCELLENCE** -...

  • Director Medical Affairs Benelux

    il y a 1 mois

    Wavre, Belgique Abbott Laboratories Temps plein

    **Medical Manager, Abbott Diabetes Care (BENELUX)** **Location**: Headquarters in Belgium **Primary Function**: - Interact with key stakeholders in the medical community, providing training and scientific advice on Abbott Diabetes Care monitoring solutions. - Contribute to the design of local clinical trials, ensuring meaningful differentiation of Abbott...

  • Senior Director, Global Content Creation Oncology

    Il y a 2 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, Philadelphia Walnut Street, UK - London - New Oxford Street, USA - North Carolina - Durham **Posted Date**: Oct 4 2024 The purpose of the **Senior Director, Global Content Creation Oncology r**ole is to develop, maintain and oversee the development and delivery of the Global...

  • Safety Physician

    Il y a 2 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre, UK - London - New Oxford Street **Posted Date**: Oct 21 2024 **Job purpose**: Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data and management of safety...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Herpes zoster**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Pneumococcal MAPS**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - RSV**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market...