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Senior Pharmacovigilance Scientist

hace 1 mes

Barcelona, Barcelona, España Neuraxpharm A tiempo completo

About the Role:

We are seeking a highly skilled Senior Pharmacovigilance Scientist to join our Corporate PV team in Barcelona, Sant Joan Despi. As a key member of our team, you will be responsible for supporting safety management activities for all Neuraxpharm products.

Key Responsibilities:

  • Support safety management activities of all Neuraxpharm products.
  • Carry out PV activities in line with current local and global PV requirements.
  • Prepare, review and monitor PV contracts (national and international for the group).
  • Coordinate the preparation and review of periodic safety reports and risk management plans.
  • Monitoring and oversight of signal detection activities.
  • Organise, create, and implement risk minimisation measures, including PV educational materials.
  • Create standard operating procedures for the PV Department.
  • Ensure that PV activities for the company sponsored clinical trials are in line with company SOPs and applicable regulations.
  • Adhere to relevant Neuraxpharm PV Corporate SOP and local PV SOP, Working Instructions and templates.
  • Participate in the preparation, execution and follow-up of PV audits and/or inspections.

Requirements:

  • At least 5 years of experience within the pharmacovigilance disciplines in the pharmaceutical industry.
  • Experience in PV related environments, preferably at local, regional and global levels.
  • Experience in Local / Global safety regulations and standards (e.g., ICH, EU Regulation).
  • Experience in Clinical Trial EU Regulation.
  • Knowledge of legislation in force concerning pharmacovigilance.
  • Advanced level management of MS Word, MS Excel, MS Access, and MS Outlook.
  • Bachelor or master's degree in life sciences (Degree in Pharmacy, Medicine, Biology, Chemistry or similar).
  • Specific training in pharmacovigilance.
  • Fluent English.
  • Knowledge of other European languages (Spanish, German, French) will be valuable.

What We Offer:

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders.

We offer a unique opportunity to work in a dynamic and innovative environment, with a strong focus on patient care and safety.

As a Senior Pharmacovigilance Scientist, you will have the opportunity to work with a talented team of professionals, and contribute to the development of our CNS products.

We are committed to providing a supportive and inclusive work environment, and offer a range of benefits and perks to our employees.

Join us in our mission to improve patients' lives and make a difference in the CNS area.