Drug Safety Specialist

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 ?

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.
3. Life and accident insurance.
4. ️ Ticket restaurant
5. On-site medical service
6. Benefits and Savings Club.
7. Training and language learning platform
8. ️ Wellness platform with unlimited free psychologist sessions
9. Cabify transportation service for employee use
10. Development plans, internal mobility policy.
11. Many more!

What will the Selection process be like? ️

️ Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

️ Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

️ Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting!

COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.