30 jul
|
Grifols
|
Madrid
Your role mission: Provides operational support for integral pharmacovigilance activities for Grifols investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data reviews and management of the integrated database utilized by worldwide Grifols pharmacovigilance personnel.
What your responsibilities will be
Participate in safety data collection, review, processing, evaluation, analysis and compilation.
Process adverse event case reports for marketed products, define required submissions, and conduct follow‑up with reporters.
Compile and reconcile information to prepare documentation required by pharmacovigilance legislation.
Review weekly literature and updates in pharmacovigilance legislation, ensure compliance with archiving tasks, and compile information for periodic safety update reports.
Ensure quality and compliance with legal requirements,
support staff in audits and inspections, provide training, and support review and update of SOPs.
Perform PV database operating activities: query data extraction, ensure data consistency and integrity, and support updates in database configuration.
Who you are
Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry). A Master's or Postgraduate degree in the pharmaceutical sector and/or in Pharmacovigilance is valuable.
1–2 years of experience in a similar position within the pharma industry (CRO or pharmaceutical company), highly valued.
Knowledge of MS Office and SAP.
Advanced level of English.
Benefits package Schedule: Monday‑Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same flexible start time).
Contract of Employment: Permanent position.
Grifols is an equal opportunity employer.
📌 Drug Safety Officer (Madrid)
🏢 Grifols
📍 Madrid