Descripción de la oferta
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 ResponsibilitiesManage 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 SkillsDegree 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 HavePrevious 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 DetailsStart Date: ASAPLocation: 100% RemoteIf you're interested or know someone who could be a great fit, feel free to reach out. Let op: vacaturefraudeHelaas 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).* Twijfel je over de echtheid van een vacature of contactpersoon? Neem dan altijd rechtstreeks contact met ons op via de officiële contactgegevens op onze website. Important: job fraudUnfortunately, job fraud is becoming more common. Beware of such scams:* 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.
