Drug Safety Specialist - Temporary

Insud Pharma; Madrid; On-site; EUR 42,000 - 54,000; Full time

Job summary

Exeltis, part of Insud Pharma, seeks a Drug Safety Specialist in Madrid to join the Pharmacovigilance team on a temporary basis. You will manage adverse events and support global safety activities, leveraging PV systems in an international setting.

The ideal candidate has 2+ years in pharmacovigilance, a Life Sciences degree, and fluency in Spanish and English, to ensure compliance with evolving regulations and business requirements.

Qualifications

• Degree in Life Sciences such as Pharmacy, Biochemistry, or Biology; a medical degree, Master’s degree, or PhD will be valued.
• At least 2 years of experience in a Pharmacovigilance department.
• Experience with Good Pharmacovigilance Practices and quality systems applied to Pharmacovigilance.
• Experience in an international environment.
• Knowledge of pharmacovigilance legislation (EU GVPs and UK PV).
• 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.

Responsibilities

• 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.

Skills

Analytical skills

Interpersonal skills

Initiative

Adaptability

Flexibility

Responsibility

Education

Life Sciences degree

Master’s degree or PhD valued

Tools

PV databases

Job description

Position: Drug Safety Specialist - Temporary

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, Master’s 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.

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