Corporate Pharmacovigilance Senior Scientist

hace 1 semana

Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo
About the Role

We are seeking a highly skilled Pharmacovigilance Senior Scientist to join our team at Neuraxpharm. As a key member of our Corporate PV department, you will play a crucial role in ensuring the safety of our medicinal products and complying with regulatory requirements.

Key Responsibilities
  1. Support the management of safety profiles for all Neuraxpharm products.
  2. Conduct pharmacovigilance activities in accordance with local and global regulations.
  3. Prepare, review, and monitor PV contracts, including national and international agreements.
  4. Coordinate the preparation and review of periodic safety reports and risk management plans.
  5. Monitor and oversee signal detection activities.
  6. Develop and implement risk minimization measures, including PV educational materials.
  7. Create standard operating procedures for the PV Department.
  8. Ensure that PV activities for company-sponsored clinical trials align with company SOPs and applicable regulations.
  9. Adhere to relevant Neuraxpharm PV Corporate SOPs and local PV SOPs, working instructions, and templates.
  10. Participate in the preparation, execution, and follow-up of PV audits and/or inspections.
Requirements
  1. At least 5 years of experience in pharmacovigilance disciplines within the pharmaceutical industry.
  2. Experience in PV-related environments, preferably at local, regional, and global levels.
  3. Knowledge of local and global safety regulations and standards, including ICH and EU Regulation.
  4. Experience in Clinical Trial EU Regulation.
  5. Advanced level management of MS Word, MS Excel, MS Access, and MS Outlook.
  6. Bachelor or master's degree in life sciences, with specific training in pharmacovigilance.
  7. Fluent English, with knowledge of other European languages (Spanish, German, French) a plus.
  8. Availability to travel: 10%.
About Neuraxpharm

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. With a unique understanding of the CNS market built over 35 years, we are constantly innovating, with new products and solutions to address unmet patient needs. Our company has approximately 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries.

We are backed by funds advised by Permira and manufacture many of our pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.

What We Offer
  1. Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
  2. Attractive remuneration according to experience and skills provided.
  3. An inspiring leadership team that drives performance.
  4. An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, result-focused, and expert team.

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We respect and celebrate the diversity of our people, their backgrounds, and experiences and provide equal opportunity for all.

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