SERM Associate Scientific Director

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Overview

We are looking for a SERM Associate Scientific Director to join our team.

As the successful candidate you will provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in the post-marketing setting and late stage clinical development.

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. Make recommendations for the further characterization, management, and communication of safety risks.

Focus on efficiency and effectiveness to meet the needs of our Patients and Healthcare Professionals. 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 Life at GSK page.

Responsibilities

  • Be responsible for signal detection and evaluation activities for assigned products.

  • Drive production of regulatory periodic reports and associated documentation and risk management plans (RMPs) globally according to the agreed process and timelines; advise on content of regulatory period reports in partnership with the product physician.

  • Prioritise activities effectively to meet multiple deadlines with attention to detail and high quality standards.

  • Support and facilitate safety governance and safety review teams in clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues and ensure risk-reduction strategies are implemented in clinical study protocols and/or product labeling.

  • Build strong collaborative relationships and demonstrate matrix leadership; provide input to matrix teams on safety issues and processes. Ability to coach and mentor others.

  • Possess effective communication skills and be able to present ideas and data clearly to matrix teams and senior staff at governance committees, with the ability to listen and respond to others.

Qualifications & Skills

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

  • Health Sciences/Health Care Professional degree (or equivalent) required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.

  • 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.

  • Experience working in large matrix organizations.

  • Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.

Why GSK?

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement between the employment business/agency and GSK. In the absence of such written authorization any actions by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or referrals.

Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance with federal and state US transparency requirements. For more information, please visit the CMS Open Payments data site.

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Location:
City Of London, England, United Kingdom
Salary:
£125,000 - £150,000
Job Type:
FullTime
Category:
Other

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