Drug Safety Specialist

Position: Drug Safety Specialist

Location: Madrid

Experience: 2 year of experience in Pharmacovigilance

Want to know more

Exeltis is a global pharmaceutical company specialized in the development and commercialization of innovative value-added products for health.

Exeltis is part of Insud Pharma an international pharmaceutical group operating across the entire value chain providing specialized knowledge and expertise in scientific research development manufacturing sales and marketing of active pharmaceutical ingredients (APIs) finished dosage forms (FDFs) and branded pharmaceutical products adding value to both human and animal health.

We are currently looking for a Drug Safety Specialist to join the Pharmacovigilance team in Madrid. This is an excellent opportunity for a professional with experience in pharmacovigilance who is looking to continue developing their career in an international dynamic and highly specialized environment.

What are we looking for

We are looking for a professional who will contribute to ensuring compliance with applicable regulations and internal pharmacovigilance procedures while actively supporting the management of global safety activities.

The challenge!

• Establish and maintain relationships with local Pharmacovigilance departments across Exeltis to ensure compliance with applicable regulations and company procedures.
• Support the maintenance of the Pharmacovigilance Quality System including the drafting updating and implementation of Global Standard Operating Procedures (SOPs).
• Contribute to the continuous monitoring of the benefit-risk balance of products.
• Manage adverse events from post-marketing sources ensuring expedited reporting to the applicable Health Authorities when required.
• Perform worldwide scientific literature monitoring.
• Conduct safety monitoring activities for interventional Phase I II and III clinical trials.
• Carry out safety monitoring for post-authorization safety studies market access activities and other Phase IV projects.
• Contribute to ensuring compliance with pharmacovigilance activities including case reconciliation with relevant departments affiliates distributors and business partners.
• Calculate KPIs for the Pharmacovigilance area.
• Participate in audits and inspections when required as well as in the implementation and follow-up of CAPAs until closure.
• Maintain Pharmacovigilance files in a secure accurate updated and complete manner in compliance with internal standards and applicable regulations.

What do you need

• Degree in Life Sciences such as Pharmacy Biochemistry or Biology; a medical degree Masters degree or PhD will also be valued.
• At least 2 years of experience in a Pharmacovigilance department.
• Experience in Good Pharmacovigilance Practices and quality systems applied to Pharmacovigilance.
• Experience working in an international environment.
• Knowledge of current pharmacovigilance legislation ideally European GVPs and UK PV legislation.
• Knowledge and hands-on experience with electronic Pharmacovigilance databases.
• Experience in Pharmacovigilance activities in the context of Clinical Trials.
• Fluent level of Spanish and English.
• Strong analytical skills initiative adaptability flexibility responsibility and good interpersonal skills.

Do you think this opportunity is not for you

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