TECHNICAL DRUG SAFETY OFFICER

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Mission

Provides operational support for global Pharmacovigilance (PV) activities for Grifols investigational and marketed products. Ensures Drug Safety, Pharmacovigilance deliverables are of the highest quality and meet global Regulatory Reporting timelines. Responsible for Safety Data Analysis, Data Review, and management of the integrated Safety Database utilized by worldwide Grifols pharmacovigilance personnel.

What your responsibilities will be

• To participate in the safety data collection, review, processing, evaluation, analysis and compilation:
  • Participate in the extraction, review and analysis of information from the pharmacovigilance database, performing Safety Information Analytics, Safety Data Analysis, Data Extraction, Data Review, and Data Management.
• Compilation and reconciliation of information in order to prepare documentation required by pharmacovigilance legislation:
  • Process and review safety data to develop Aggregate Safety Reports.
  • Support responses to requests from regulatory agencies, ensuring Regulatory Compliance.
  • Coordinate and manage creation of SQL queries for Data Extraction used in different PV documents.
  • Develop training documentation and/or work instructions to determine methods and procedures.
  • Work as Signal Analyst during Signal Detection and Signal Management activities, including extraction of signal detection reports and ensuring document filing and archiving.
• Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities:
  • Support pharmacovigilance staff involved in audits and inspections (Quality Assurance, GVP Compliance).
  • Provide training to concerned personnel based on the training plan.
  • Support the review and update of SOPs.
  • Interact with Regulatory Affairs Department regarding Aggregate Safety Reports and other documents required by Regulatory Authorities.
• PV database operating activities:
  • Use SQL queries for Data Extraction for different PV documents.
  • Ensure Data Consistency, Data Integrity, and Data Quality within the Safety Database.
  • Support updates in the database configuration, collaborating with IT and Database Administration activities.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry), with a Master's or Postgraduate degree in the pharmaceutical sector and/or Pharmacovigilance, Bioinformatics, Biostatistics, or Data Analytics considered an asset.
• 1–2 years of experience in a similar position within the pharmaceutical industry (CRO or pharmaceutical company).
• Experience with Excel, Excel Macros, SQL, Business Objects, RStudio, Data Analytics, or Business Intelligence tools is highly valued.
• Knowledge of E2B(R2), E2B(R3), MedDRA, WHO Drug Dictionary, and medical terminology is considered an advantage.
• Advanced level of English.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Benefits package

Flexibility for U Program : Hybrid Model.

Contract of Employment: Permanent position.

Grifols is an equal opportunity employer.