Overview
Mission: Patient safety.
Management of corporate pharmacovigilance activities in collaboration with different internal and external stakeholders to ensure the safety of the assigned Almirall marketed or investigational products.
Responsibilities
Operational and medical support to clinical trial activities including but not limited to SAE management and medical review, reconciliation, unblinding activities as well as support in safety monitoring activities during development as applicable.
For clinical trials, responsible for management and medical input of Aggregate Reports (DSUR), and any other periodic reports required.
Revision of the synopsis, safety section of the protocols, safety section of the Data Management Plan, Safety Topics of Interest.
Medical lead for the creation of the Safety Reporting Plan.
Active participation in the clinical study team meetings, both internal and with the CRO.
Operational and medical support to non-interventional studies, market research, registries activities etc. including but not limited to ICSR management and medical review, reconciliation tasks, as well as support in safety monitoring activities.
Post-marketing safety surveillance activities, including medical review and medical assessment.
Supports the Patient Safety Director and EUQPPV to fulfil internal duties as well as responsibilities towards authorities.
Contributes to the establishment and performance of the Pharmacovigilance Quality Management System, and implements the procedures required by internal and applicable legislation.
Safety database tasks as applicable.
Signal detection tasks either as medical writer or medical reviewer.
PSUR and RMP medical review.
Education
Medical Doctor
Relevant post-graduate training in pharmacovigilance and/or clinical safety and/or epidemiology preferred.
Specific Knowledge
Safety databases.
GVPs and other regulations as needed.
Experience
Relevant PV experience preferred.
Clinical safety expertise in a corporate safety department is appreciated.
Why work with Almirall?
We are a people-centric company where employees are at their best, patients and customers are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
This role is based in Sant Feliu de Llobregat, Catalonia, Spain (location subject to change).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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