Clinical Safety Operations Manager

PRA Health Sciences; Almería; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company dedicated to improving patients' lives through innovative safety strategies in clinical trials. As a Manager of Clinical Safety Operations, you'll lead efforts in ensuring compliance and driving continuous improvement in safety processes. This role offers a unique opportunity to work in a supportive environment that values independence and collaboration. With a focus on well-being and work-life balance, this position comes with competitive benefits and the chance to make a significant impact in the field of drug safety.

Servicios

Annual Leave

Health Insurance

Retirement Planning

Employee Assistance Programme

Life Assurance

Flexible Benefits

Formación

• Extensive experience in pharmacovigilance and clinical development.
• Proven project and process management skills.

Responsabilidades

• Oversee operational safety aspects and ensure compliance with Pharmacovigilance.
• Manage medical safety follow-up queries and reconciliation activities.

Conocimientos

Pharmacovigilance

Project Management

Clinical Development

Communication Skills

Intercultural Collaboration

Educación

University Degree in Scientific Fields

Descripción del empleo

Working in ICON Strategic Solutions is more than a job; it’s a calling for people who care and are passionate about improving patients’ lives. We value courage in career transitions and provide an open, friendly work environment that empowers our employees and offers opportunities for long-term development.

Our team members enjoy independence in their roles, supported by experienced leadership when needed. If you seek a meaningful career, ICON Strategic Solutions is the place for you.

Responsibilities

The Manager Clinical Safety Operations contributes to effective safety strategies for assigned processes and oversees operational safety aspects. This includes providing expertise and guidance to Global Drug Safety functions, other company departments, and vendors involved in safety tasks. The role also involves developing, implementing, and documenting processes to ensure Pharmacovigilance compliance, defining process KPIs, monitoring performance, and driving continuous improvement. Ensuring vendor compliance in clinical trials and post-authorization studies is also key.

The Manager Clinical Safety Operations is responsible for:

• Managing processes for medical safety follow-up queries for ICSRs from clinical trials and post-authorization studies, including SAE reconciliation activities.
• Reconciliation of ICSRs with partners and sources like Global Medical Information.
• Maintaining the study protocol library and product dictionary in the global safety database (ARISg).
• Reviewing safety sections of trial documents (e.g., Drug Safety Manual, Safety Processing Plan).
• Contributing to resource and budget planning for trials.
• Aligning safety activities and guidelines with partners and service providers, ensuring consistency with GDS processes.

Qualifications, Education, and Languages

• Health Care Professional with extensive experience in pharmacovigilance, clinical development, project management, or IT Systems.
• Fluent in written and spoken English.
• A university degree or equivalent professional experience in scientific fields.
• Proven project and process management skills.

Professional Experience

• 5-7 years of experience in Drug Safety or Clinical Trial Safety Management.
• Experience leading or participating in Drug Safety Monitoring Committee meetings.
• Experience drafting and managing ICFs.
• Strong understanding of regulations related to drug safety in development and post-authorization.
• Excellent communication skills in an international environment.
• Intercultural collaboration experience in matrix teams.

What ICON Offers

We prioritize building a diverse, high-performing culture that nurtures talent. Besides a competitive salary, we offer various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements.
• Health insurance options for you and your family.
• Retirement planning services.
• Global Employee Assistance Programme with 24/7 access to professional support.
• Life assurance.
• Flexible benefits like childcare vouchers, gym discounts, travel passes, and health assessments.

Visit our careers website for more information about working at ICON.

ICON is an equal opportunity employer committed to a discrimination-free workplace. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need accommodations during the application process due to a medical condition or disability, please let us know or submit a request.

If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be the perfect fit for this or other roles at ICON.