SENIOR PHARMACOVIGILANCE SPECIALIST
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.
Job description
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
Requirements:
· 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
What would you achieve:
· 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