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About this job
Key facts
Senior Patient Safety
Contract
No
Barcelona, Catalonia, Spain
Negotiable €
For one of our key clients in the pharmaceutical industry, we are looking for two experienced professionals to join the Corporate Patient Safety function and support strategic pharmacovigilance activities across clinical development and marketed products.
Key Responsibilities
- Manage corporate pharmacovigilance activities for marketed and investigational products.
- Lead the preparation and management of PSURs, DSURs, aggregate reports, and other periodic safety submissions.
- Support clinical trials through SAE management, reconciliation activities, and safety monitoring.
- Act as Subject Matter Expert for PSUR and literature review activities.
- Participate in clinical study teams and collaborate with CROs, affiliates, and external partners.
- Support pharmacovigilance agreements, regulatory activities, and safety governance processes.
- Contribute to auditing, inspections, CAPA implementation, and Pharmacovigilance Quality Management System activities.
- Provide pharmacovigilance training and support to internal teams and vendors.
Required Skills
- Degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine, or related field.
- 5+ years of experience in Pharmacovigilance.
- Strong experience managing PSURs, DSURs, and aggregate safety reporting activities.
- Experience working with safety databases, MedDRA, and EudraVigilance.
- Knowledge of pharmacovigilance regulations and quality systems.
- Excellent communication, stakeholder management, and organizational skills.
- Fluent English and Spanish.
Nice to Have
- Previous experience in Clinical Development environments.
- Experience supporting audits and health authority inspections.
- Expertise in Pharmacovigilance Quality Management Systems.
- Experience coordinating external vendors, affiliates, and CROs.
Position Details
Start Date: ASAP
Location: 100% Remote
If you're interested or know someone who could be a great fit, feel free to reach out.
Let op: vacaturefraude
Helaas komt vacaturefraude steeds vaker voor. We waarschuwen je voor mogelijke misleiding:
* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).
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Important: job fraud
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* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.
* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.
