Technical Drug Safety Officer

Grifols, S.A; Sant Cugat del Vallès; On-site; EUR 47,000 - 65,000; Full time

Benefits offered by this job

Temporary position

Job summary

Grifols, S.A. is seeking a Technical Drug Safety Officer to provide operational support for global pharmacovigilance activities across investigational and marketed products.

You will ensure high-quality deliverables and timely regulatory reporting, while managing the PV database used by worldwide Grifols teams. You will participate in data collection, processing and reconciliation, perform safety reviews, and support SOP updates and training.

Qualifications

• Bachelor's degree in Health Sciences; a Master or Postgraduate in pharma/pharmacovigilance is valuable.
• 1–2 years of experience in a similar pharma role (CRO or company) is highly valuable.
• Knowledge of MS Office and SAP program.
• Advanced level of English.

Responsibilities

• Participate in safety data collection, review, processing, evaluation, analysis and compilation.
• Process adverse event case reports for Grifols marketed products, including follow-up with reporters.
• Prepare documentation required by pharmacovigilance legislation; review literature and regulatory updates.
• Support audits/inspections and provide training per plan.

Skills

MS Office

English (Advanced)

Education

Bachelor's in Health Sciences (Pharmacy/Biology/Chemistry)

Tools

SAP

Job description

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.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20,000 people. That’s why we need a Technical Drug Safety Officer like you.

Your role mission: Provides operational support for global 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

• To participate in the safety data collection, review, processing, evaluation, analysis and compilation:
• Processing Grifols marketed products adverse event case reports (including definition of submissions required and conducting follow-up with reporters).
• Compilation and reconciliation of information in order to prepare documentation required by pharmacovigilance legislation:
• Review of the weekly literature review.
• Review of the updates in pharmacovigilance legislation.
• Compliance with archiving tasks for deliverables and relevant documents.
• Compilation of information for and participation in preparation of periodic safety update reports.
• Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities:
• Support to the pharmacovigilance staff involved in audits and inspections
• Provide training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departments
• Support to the review and update of the SOPs, working practices or conventions
• PV database operating activities:
• Use of queries for data extraction for different PV documents.
• Ensure data consistency and integrity within the safety database.
• Support to updates in the database configuration..

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), being valuable to have a Master or Postgraduate degree in the pharmaceutical sector and/or in Pharmacovigilance.
• You have 1-2 experience in a similar position within pharma industry (CRO or pharmaceutical company), being high valuable.
• You have knowledge of MS Office and SAP program.
• You have 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.

Information about Grifols is available at www.grifols.com.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Benefits package

Contract of Employment: Temporary position