Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles.
Primary Duties and Responsibilities
- Deputy EU QPPV for assigned projects.
- Local (deputy) QPPV for assigned projects – Spain.
- Project Lead for assigned projects. Maintain Safety Management Plan or other technical document. Responsible for monthly reporting.
- Provide supervision to Pharmacovigilance Associates for project related activities.
- Participate in the elaboration of proposal for new Clients and/or new projects for existing Clients.
- Database administrator for assigned projects. Assist in the validation of the safety database at Viglya. Participate in MedDRA 6-monthly update as needed.
- Oversee the management of incoming individual case safety reports (ICSRs) for marketed products and serious adverse events (SAEs) for interventional studies throughout their review process up to distribution to Client. Propose follow–up queries as needed.
- Perform peer review of processed ICSRs/SAEs. Determine reportability of ICSRs to relevant competent authorities. Data entry in safety database and coding backup.
- Periodic QC of scientific literature reviews for assigned projects.
- Oversee expedited and periodic safety submissions to regulatory authorities (EVWeb posting/data entry; regulatory authorities’ portals).
- Author and track PSURs/PBRERs/PADERs and DSURs with input from Safety Physician/ Client.
- Author RMPs with input from Safety Physician and Client where needed.
- Conduct signal management activities with input from Safety Physician.
- Create, maintain, and track Reference Product Information for assigned projects.
- Create, maintain, and track pharmacovigilance agreements with client’s third-party providers/partners.
- Assist in tracking worldwide pharmacovigilance related regulations and guidelines (for both investigational and marketed products).
- Participate in the design of PV training programs for Clients. Generate and deliver tailor-made training.
- Ability to work on multiple projects concurrently, in a fast paced, evolving environment, under strict deadlines.
- Good leadership, organization and communication skills.
- Detail-oriented and committed to producing high quality results.
- Influential, creative and proactive team player.
- Excellent computer skills including understanding of Microsoft Office products (Word, Excel, PowerPoint).
- Fluent (read, write, speak) in English and Spanish; additional languages a plus.
Experience/ Candidate Profile
- 1-5 years of experience in the Pharmaceutical/Biotech industry in other functions and departments such as Regulatory Affairs, Clinical, Medical Affairs.
- 1-3 years of experience in a pharmacovigilance department.
- Knowledge in electronic reporting (digital certificate; EVWeb posting/data entry).
- Pharmacist, nurse, biologist. Science degree
- Barcelona, Spain.
Point of contact
firstname.lastname@example.org / website
6 months followed with indefinite contract.
To be discussed during the interview process.