▷ 15h Left: SERM Scientific Director

Site Name: UK – London – New Oxford Street, WarsawRzymowskiego 53 Posted Date: Apr 8 2025 Job Purpose Responsible tolead medical and scientific staff within the SERM (SafetyEvaluation & Risk Management) and defining and driving thestrategy and vision of clinical safety and pharmacovigilanceactivities in alignment with Global Safety business strategies. Asa senior member of the Global Safety organization the role isresponsible to: - Implement policy, processes and support theimplementation of operational and strategic plans. - Ensurescientifically sound review and interpretation of data andmanagement of safety issues and escalates safety issues identifiedthrough the safety review process to senior management and safetygovernance as appropriate. Makes recommendations for the furthercharacterization, management, and communication of safety risks. -Focus on efficiency and effectiveness to meet the needs of ourPatients and HCPs. Supporting the pharmacovigilance andbenefit-risk management of the assigned portfolio of GSK globalassets to ensure Patient Safety globally. Key ResponsibilitiesScientific/Medical Knowledge PV Expertise - Expert in clinicalsafety and pharmacovigilance activities. - Demonstrated record ofsound judgement and decision making in safety evidence generation,benefit-risk assessment, causality assessment, evaluation of safetysignals, and of proactive risk management strategies includingmanagement of labelling changes, physician and patient educationand monitoring of safety issues in the real world. - Coaches andmentors SERM colleagues in the [scientific/medical] aspects ofsignal evaluation methodology and risk management and preparationof regulatory safety reports and other documents. - Demonstratedtrack record of quality decision making and creative problemresolution in critical situations, based on assessment of allrelevant supporting and conflicting information/factors andunderstanding of the wider context. - Provides excellentmedical/scientific judgment, strong analytical skills, proactiveapproach in drug safety and high sense of urgency. -Champions/sponsors safety governance by development of safetystrategy and its execution for products in clinical development andpost marketing settings. Anticipates, detects and addresses productsafety issues and ensures that risk-reduction strategies areimplemented appropriately. - Leads cross-GSK activities such assafety advisory panels, interfaces with and assumes ad hocmembership of a Senior Governance Committee. - Ability to engagein, and contribute to, broad GSK environment and pharmacovigilanceenvironment outside GSK with confidence, impact, integrity andprofessionalism. Cross-functional Matrix team leadership -Champions/sponsors safety governance by development of safetystrategy and its execution for products in clinical development andpost marketing settings. Anticipates, detects and addresses productsafety issues (e.g., product incidents) and ensures thatrisk-reduction strategies are implemented appropriately. - Provenability to affect department, or product strategies with a strongunderstanding and ability to incorporate global considerations intodecision making. - Builds strong collaborative relationships anddisplays excellent leadership skills on safety issues whilstworking in a matrix team, with an outstanding track record leadinga team in a matrix setting. - Demonstrates resilience and abilityto adjust behaviours and priorities based on changing environment.- Leads or oversees SERM contribution to due diligence activities.Communications (verbal, written) and Influencing (internal PVGovernance and External LTs) - Excellent communication (verbal,written) and influencing (internally and externally) skills. -Leads cross-GSK activities such as safety advisory panels,interfaces and assumes ad hoc membership of a Senior GovernanceCommittee. Influences others external to GSK to meet organisationalobjectives and may be recognised as a key player in externalinternational pharmacovigilance activities (i.e., may be a memberof trade association or external initiatives). - Leads drivingchange until their implementation. - Recognised as an authoritywith expert knowledge of relevant pharmacovigilance regulations andmethodologies applicable to SERM activities. Why you? BasicQualifications: We are looking for professionals with theserequired skills to achieve our goals: - Health Sciences/Health CareProfessional degree required (e.g., PharmD, PhD, BSN/MSN/NP, BSc,MS). - Comprehensive experience in the Pharmaceutical or Biotechindustry working in Drug Safety or Pharmacovigilance relating toSafety Evaluation and Risk Management, encompassing both clinicaldevelopment and post-marketing activities. - Knowledge/experienceof international pharmacovigilance requirements (e.g., ICH, GVPmodules, CIOMS initiatives) and drug development and approvalprocesses. Preferred Qualifications: If you have the followingcharacteristics, it would be a plus: - Advanced Degree. -Experience working in large matrix organisations. - Experience inOncology/Immunology. Why GSK? Uniting science, technology andtalent to get ahead of disease together. GSK is a global biopharmacompany with a special purpose – to unite science, technology andtalent to get ahead of disease together – so we can positivelyimpact the health of billions of people and deliver stronger, moresustainable shareholder returns – as an organisation where peoplecan thrive. We prevent and treat disease with vaccines, specialtyand general medicines. We focus on the science of the immune systemand the use of new platform and data technologies, investing infour core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on ourpeople. While getting ahead of disease together is about ourambition for patients and shareholders, it’s also about making GSKa place where people can thrive. We want GSK to be a place wherepeople feel inspired, encouraged and challenged to be the best theycan be. A place where they can be themselves – feeling welcome,valued, and included. Where they can keep growing and look aftertheir wellbeing. So, if you share our ambition, join us at thisexciting moment in our journey to get Ahead Together. As an EqualOpportunity Employer, we are open to all talent. In the US, we alsoadhere to Affirmative Action principles. This ensures that allqualified applicants will receive equal consideration foremployment without regard to neurodiversity, race/ethnicity,colour, national origin, religion, gender, pregnancy, maritalstatus, sexual orientation, gender identity/expression, age,disability, genetic information, military service,covered/protected veteran status or any other federal, state orlocal protected class*(*US only). We believe in an agile workingculture for all our roles. If flexibility is important to you, weencourage you to explore with our hiring team what theopportunities are. Should you require any adjustments to ourprocess to assist you in demonstrating your strengths andcapabilities contact us on or . 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