SERM Medical Director / SERM Scientific Director

Job description

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. Scientific/Medical Knowledge PV ExpertiseLeads 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. Safety governance and cross-functional matrix leadershipLeads 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. Communication, Influencing and Inspection readinessLeads 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. Basic RequirementsCandidates must meet the requirements for both roles and all requirements for the applicable Medical Director or Scientific Director pathway. Requirements for Both RolesRelevant 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. SERM Medical Director RequirementsMedical 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. SERM Scientific Director RequirementsA 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. SERM Medical Director Preferred RequirementsBoard certification, specialist registration, or an additional relevant medical or scientific postgraduate qualification. SERM Scientific Director Preferred RequirementsAn 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 Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques Polish Salary Range / Polski przedział wynagrodzenia: PLN 419,250 to PLN 698,750Italian Salary Range / Fascia retributiva in Italia: EUR 95,250 to EUR 158,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced c