Drug Safety Specialist

Madrid , Community of Madrid, Spain

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: Exeltis
Region: Madrid , Community of Madrid

In a few words

Position: Drug Safety Specialist (Maternity Leave)

Location: Madrid.

Want to know more?

Exeltis is an organization that develops innovative treatments and targets the unmet medical needs of individuals, families and healthcare professionals. It has nearly 4,000 professionals in over 40 countries. A company born from innovation and the desire to offer the highest quality to everyone.

Exeltis is a leader in the field of Women''s Health. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world.

Exeltis has one overarching goal: to offer women support and care throughout every single stage of their lives

Ready to be a #Challenger?

What are we looking for?

We are seeking a highly experienced Drug Safety Specialist to join our Pharmacovigilance team at Exeltis Headquarters in Madrid. The successful candidate will provide critical support to the EU Qualified Person Responsible for Pharmacovigilance (QPPV) by ensuring compliance and excellence in drug safety activities across the organization.

The challenge!

• Provide oversight and management of business partners and vendors involved in pharmacovigilance activities.
• Maintain and update the Quality Management System (QMS) and Pharmacovigilance System Master File (PSMF) to ensure regulatory compliance.
• Prepare and contribute to the writing of aggregate safety reports.
• Offer support and guidance to local affiliates regarding pharmacovigilance requirements and processes.
• Manage Pharmacovigilance Agreements (PVA) contracting and related documentation.

What do you need?

• Languages: Fluent Spanish and English.
• Experience (years/area): 5 to 10 years of proven experience in Pharmacovigilance.
• Specific Knowledge: Strong knowledge of pharmacovigilance regulations and guidelines within the EU. Experience in managing vendors and business partners in a pharmacovigilance context. Excellent report writing and communication skills. Ability to work collaboratively with cross-functional teams and local affiliates.

Our benefits!

1. Flexible start time from Monday to Friday (full-time).
2. Attractive salary package.

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