SERM Medical Director / SERM Scientific Director

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Job Purpose

Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets for complex Classic & Established Products with ongoing litigation.

Ensures scientifically sound review and interpretation of large and complex datasets, management of safety issues and escalates issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for further characterization, management and communication of safety risks.

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for complex data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem solving, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high-performance standards for quality.

• Leads safety governance by development of safety strategy and its execution for Classic & Established Products.
• Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
• Leads and facilitates Safety Review Teams/safety governance to detect and address product safety issues and ensures that endorsed risk-reduction strategies are implemented appropriately.
• Leads discussions/interactions with Global asset and litigation lawyers.
• Leads cross-functional ad hoc teams to address urgent and important product safety issues.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, GLC, QPPV).
• Builds strong working relationships and exemplifies excellent leadership skills on safety issues with a demonstrated ability to lead, coach and mentor others.

• Leads presentations on recommendations of safety issues to senior staff members at the GSK Senior Governance Committees.
• Has the skillset to interact with confidence, credibility and influence at all levels of the GSK organisation.
• Represent GSK and actively contribute to safety-related discussions with health authorities, external consultants, partner companies (e.g. licensing partners), and during legal depositions
• Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements.
• Must have an inspection readiness mindset and be prepared as needed to support audits/inspections at short notice.

Candidates must meet the requirements for both roles and all requirements for the applicable Medical Director or Scientific Director pathway.

• Relevant degree qualification.
• Experience in the pharmaceutical or biotechnology industry in Pharmacovigilance, Drug Safety, Clinical Development, or a related field.
• Pharmacovigilance experience in safety evaluation and risk management involving clinical-development or post-marketing products.
• Knowledge of international pharmacovigilance requirements and frameworks, including ICH guidance, Good Pharmacovigilance Practices modules, or CIOMS guidance.
• Knowledge of drug-development and regulatory-approval processes.
• Experience working in a cross-functional matrix organization.

• Medical Doctor or equivalent physician qualification, such as an MD, MBBS, MBChB, or equivalent primary medical degree.
• Completion of formal postgraduate clinical training, such as a residency or recognized specialty-training program.
• Medical and scientific expertise relevant to safety evaluation and risk management in clinical-development or post-marketing settings.
• Experience applying clinical judgment to the review and interpretation of safety data, benefit-risk assessments, risk-management recommendations, or product-safety communications.

• A Health Sciences or Healthcare Professional qualification in a relevant discipline, including one of the following:
  • Bachelor's or master's degree in a relevant health-sciences discipline;
  • RN, BSN, MSN, or Nurse Practitioner qualification; or
  • RPh, BPharm,
• Scientific expertise relevant to literature evaluation, clinical-data synthesis and interpretation, safety evaluation, risk-management planning and benefit-risk assessment.
• Experience with leading and/or contributing to the review and interpretation of pharmacovigilance data.

• Board certification, specialist registration, or an additional relevant medical or scientific postgraduate qualification.

• An advanced degree in a relevant health-sciences, scientific, pharmacy, nursing, or healthcare discipline (PhD, PharmD)

Working Arrangement
This position is based in Poland with a hybrid working model, combining time in the office and remote work to support collaboration and flexibility.

We encourage candidates who want to make an impact in patient safety and develop their careers in a supportive and inclusive environment to apply. If you are ready to share your talents with us and learn along the way, we want to hear from you. Apply today and take the next step with GSK.

Skills

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

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

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.

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 (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken 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 any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, 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 to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/