Pharmacovigilance Specialist
A Pharmacovigilance Specialist will manage adverse events and regulatory compliance. The role offers career development within an international service provider.
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Do you want to step up in your career in Pharmacovigilance? PVpharm is searching for an experienced Pharmacovigilance Specialist to provide her/his expertise in our challenging pharmacovigilance projects. You will work with complex projects in collaboration with a multidisciplinary, highly motivated and international team.
As a Senior Pharmacovigilance Specialist you will be involved with different projects and will provide your expertise within different areas of Pharmacovigilance. Your activities will be mainly:
· Create, set-up and maintain PV systems in line with company SOPs
· Manage complex PV projects
· Answer complex PV questions
· Lead/attend meetings with the team and the clients
· Receive and process Adverse Events and perform Follow-ups
· Use of EudraVigilance applications (XEVMPD, EVWEB, SPOR-OMS, CTIS)
· Provide support in the creation and review of PSURs, DSURs, RMPs, PSMF
· Provide support in signal management activities
· Support audit, inspections and implementation of CAPAs
· Weekly global or local literature review
· Complete the assigned training on time and provide pharmacovigilance training to the team and the clients
· Liaise with regulatory authorities
· And other activities that might not be listed here, as every day is different in PVpharm
· Master European GVP and local Pharmacovigilance legislation
· Life sciences education
· Experience with pharmacovigilance (at least 4 years)
· Advanced command of English (and good command of Spanish will be a plus)
· Good communication skills
· Team working experience
· Proactive and problem-solving capabilities
· Responsible and organised person
· Excellent opportunity for stepping up in your career in Pharmacovigilance
· Perfect timing to join a young and fast-growing international pharmacovigilance service provider with multiple career development opportunities.
· You will work for a company with focus on personal and professional development
· Excellent opportunity to work for different projects with important international and national pharmaceutical companies
· You will be working with highly motivated colleagues that care for each other
· Full time permanent contract
· Flexible working hours
· Hybrid / remote working in line with company policy
· Retribution depending on the experience of the candidate
PVpharm is a Madrid-based consulting and services firm specializing in pharmacovigilance (PV) and drug safety for the pharmaceutical and biotech industries. They offer regulatory, medical information, and safety services, supporting both national and international clients with drug monitoring and compliance. The company operates within the growing clinical research and regulatory outsourcing sector, providing critical infrastructure for the life sciences market.
PVpharm's main office is in Madrid, Spain, positioning it within the country's dynamic healthcare and life sciences ecosystem. The company serves an international client base, making it relevant to professionals with experience in EU pharmacovigilance regulations and global safety reporting. International hires will find an environment that values expertise in regulatory compliance and cross-border communication, with a workplace culture centered on specialized pharmaceutical services.
PVpharm · Madrid
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