Clinical Drug Safety Officer

hace 2 días

Barcelona, España Instituto Grifols SA A tiempo completo

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.

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 Clinical Drug Safety Officer like you.

**What your responsibilities will be**
- You will participate in the safety data collection, review, processing, evaluation, analysis and compilation
- You will contribute to the assessment of benefit, harm, effectiveness and risk of medicines based in the highest quality data management.
- You will process adverse event case reports and conducting follow-up (including definition of submissions required regulatory agencies accordingly).
- You will manage of Serious Adverse Events from clinical studies.
- You will be Matter Expert for documents pertaining to clinical studies
- You will contribute to ensure compliance of pharmacovigilance activities with concerned departments such as clinical team or business partners
- You will include activities but not limited to develop the safety management plan, provides pharmacovigilance training for appropriate parties, reconciliation of AE data, participates in on-going clinical trial reviews and develops and designs the SAE form.
- You will participate in the preparation of Development Safety Reports (DSURs), Periodic Update Reports (PSURs) and Risk Management Plans.

**Who you are**
- You have a Bachelor’s Degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar
- You have 1 year’s experience in a similar position in a CRO or a pharmaceutical company
- You speak fluent Spanish and English.
- You are attention to detail and meticulousness
- You have excellent communication skills with different internal and external stakeholders.
- You have planning skills and organized work habits.
- You have ability to work on multiple projects simultaneously and work under pressure

**What we offer**

**Flexible schedule**: Monday-Thursday 8-9 to 17-18h and Friday 8-15h.

**Benefits package**

**Contract of Employment**: Permanent position

**Flexibility for U Program**:2 days remote working

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.

Grifols is an equal opportunity employer.

LI-Hybrid

**#LI-ER1**

**Location**:SPAIN : España : Sant Cugat del Valles**:SC3**

Learn more about Grifols

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