Safety Manager

ASPHALION; Cataluña; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Drug Safety Manager to lead pharmacovigilance efforts. The role involves managing safety reports, engaging with authorities, and overseeing compliance. Enjoy a permanent contract with flexible working options, including remote work across Spain, and opportunities for professional growth in a diverse, inclusive environment.

Servicios

Permanent contract

Home office, hybrid, or remote work

Training and development programs

Well-being programs

Formación

• At least 5 years of experience in Pharmacovigilance.
• Minimum 2 years in team and project management.
• Experience working in an international environment.

Responsabilidades

• Conduct weekly global and local literature reviews.
• Manage Individual Case Safety Reports (ICSRs).
• Report cases to European authorities.

Conocimientos

Proactive

Communicative

Accurate

Detail-oriented

Educación

Degree in Life Sciences and 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:

1. Literature Review: Conduct weekly global and local literature reviews to stay ahead of safety insights.
2. Case Management: Handle Individual Case Safety Reports (ICSRs) and perform diligent follow-ups to safeguard patient well-being.
3. Global Safety Database: Manage case processing within our database, ensuring accuracy and completeness.
4. EudraVigilance Reporting: Report cases efficiently to European authorities.
5. Communication with Authorities: Engage with competent authorities as a key contact point.
6. Regulatory Intelligence: Keep abreast of evolving pharmacovigilance legislation and requirements globally and locally.
7. PSMF and PV SOPs: Oversee maintenance of the Pharmacovigilance System Master File and SOPs.
8. PV Audits: Conduct audits to ensure compliance and system integrity.
9. Support for EU-QPPV and PV in Spain: Provide support to ensure high standards of patient safety across the EU.
10. Safety Reports: Prepare PSURs, RMPs, ACOs, DSURs.
11. Medical Advisory: Offer expert advice to improve drug safety processes.
12. PV Agreements: Draft and review pharmacovigilance contracts.

Requirements:

1. At least 5 years of experience in Pharmacovigilance.
2. Minimum 2 years in team and project management.
3. Experience working in an international environment.
4. Degree in Life Sciences and Pharmacovigilance.
5. Advanced IT skills (MS Office).
6. Proactive, communicative, accurate, and detail-oriented.

Why work at Asphalion?

• Permanent contract.
• Home office, hybrid, or remote work (anywhere in Spain).
• Variety of projects, challenges, and growth opportunities.
• Training and development programs.
• Inclusive, high-performance environment promoting passion, flexibility, and quality.
• Multinational team with over 15 nationalities.
• Well-being programs including physical, psychological, and emotional support.
• Internal activities and corporate social responsibility initiatives.
• Equal opportunity employment.