Num relance
- Tarefas: Liderar a avaliação de segurança e gestão de riscos em produtos farmacêuticos.
- Empresa: Alphanumeric, uma empresa global focada em segurança e gestão de riscos.
- Benefícios: Trabalho remoto, contrato de 1 ano com possibilidade de extensão.
- Outras informações: Ambiente dinâmico com oportunidades de crescimento profissional.
- Porquê este emprego: Contribua para decisões estratégicas que impactam a saúde global.
- Qualificações: Grau avançado em ciências ou área da saúde e experiência em farmacovigilância.
O salário previsto situa-se entre 75600 - 92400 € por ano.
About the role
Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization.
This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs.
The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.
Expertise in some of the following therapeutic areas are requested: Classic Established products, Oncology, Respiratory, Immunology, Inflammation, Vaccines and Infectious Disease.
Location
Remote, based in Portugal.
Employment Type
Full-Time | 1-Year Contract | Potential Extension
Working Hours
Candidates must be available to work within U.
S. and/or U.
K. business time zones.
Key Responsibilities Lead safety review and risk management activities for assigned products.
Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
Support global regulatory submissions and health authority interactions.
Draft and review responses to Health Authority Requests for Information (RFIs).
Provide protocol, safety, and regulatory support to clinical development teams.
Participate in cross-functional safety governance and risk management activities.
Identify emerging safety concerns and recommend appropriate actions.
Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies.
Required Qualifications
Advanced scientific or healthcare-related degree (Ph D, Pharm D, MS, NP, RN, or equivalent).
Significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
Experience responding to Health Authority RFIs.
Strong protocol support and regulatory experience.
Excellent analytical, scientific writing, and communication skills.
Proficiency in English is mandatory.
Ability to work independently and appropriately elevate issues when needed.
Experience working effectively within global cross-functional teams.
Preferred Qualifications
Oncology experience is highly desirable but not required.
Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
Experience supporting global development programs.
Empregador para Scientific Director (serm & Clinical Safety & Pharmacovigilance) - Remote - Based In Portugal: Alphanumeric
A nossa empresa é um excelente empregador, oferecendo um ambiente de trabalho remoto que promove a flexibilidade e o equilíbrio entre vida profissional e pessoal. Com benefícios como compensação por despesas de teletrabalho e seguro de saúde privado, valorizamos o crescimento dos nossos colaboradores através de oportunidades de desenvolvimento contínuo e uma cultura de comunicação aberta e colaborativa. Junte-se a nós em Portugal e faça parte de uma equipa dedicada a impactar positivamente várias áreas terapêuticas.
