Drug Safety Manager

buscojobs España; Ourense; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Join a leading company as a Drug Safety Manager, where you'll oversee pharmacovigilance project management and lead a dedicated team focused on enhancing patient safety. This role offers flexible working options and opportunities for professional growth within a diverse, multinational environment.

Servicios

Flexible home office options

Training and personal development programs

Employee well-being programs

Formación

• At least 5 years of experience in Pharmacovigilance.
• Minimum 2 years in team and project management.

Responsabilidades

• Conduct weekly global and local literature reviews.
• Handle Individual Case Safety Reports (ICSRs).
• Prepare PSURs, RMPs, ACOs, and other safety documentation.

Conocimientos

Communication

Proactivity

Attention to Detail

Educación

Degree in Life Sciences

Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

Join our trailblazing team as a Drug Safety Manager, where you'll lead pharmacovigilance project management and inspire a team dedicated to advancing patient safety.

Main responsibilities :

• Literature Review : Conduct weekly global and local literature reviews to stay ahead of safety insights.
• Case Management : Handle Individual Case Safety Reports (ICSRs) and perform diligent follow-ups to safeguard patient well-being.
• Safety Database Management : Streamline case processing through our global safety database, ensuring accuracy and completeness.
• EudraVigilance Reporting : Report cases to European authorities efficiently and accurately.
• Communication with Authorities : Serve as a key contact point with Competent Authorities.
• Regulatory Intelligence : Keep abreast of evolving pharmacovigilance legislation and requirements globally and locally.
• Documentation and SOPs : Oversee maintenance of the PSMF and PV SOPs.
• Audits : Conduct PV audits to ensure compliance and system integrity.
• Support : Support EU-QPPV and PV personnel in Spain, ensuring high patient safety standards across the EU.
• Safety Reports : Prepare PSURs, RMPs, ACOs, DSURs, and other safety documentation.
• Medical Advisory : Provide expert advice on drug safety matters.
• PV Agreements : Draft and review pharmacovigilance contracts.

Requirements :

• At least 5 years of experience in Pharmacovigilance.
• Minimum 2 years in team and project management.
• Experience working in an international environment.
• Degree in Life Sciences or Pharmacovigilance.
• Proficiency in MS Office and advanced IT skills.
• Proactive, communicative, accurate, and detail-oriented.

Why work at Asphalion?

• Permanent contract with flexible home office, hybrid, or remote options (located anywhere in Spain).
• Variety of projects, challenges, and growth opportunities.
• Training and personal development programs.
• Inclusive, high-performance environment fostering skill development and career growth.
• Multinational team with over 15 nationalities.
• Employee well-being programs covering physical, psychological, and emotional health.
• Internal and CSR activities.
• Equal opportunity employer.