Drug Safety Officer

hace 5 días

Madrid, España Oracle A tiempo completo

Drug Safety Officer-2300043G

**Applicants are required to read, write, and speak the following languages***: English, Spanish

**Preferred Qualifications**
- Cerner Enviza, an Oracle company, is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind. Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.The Drug Safety Officer supports the creation, maintenance and implementation
of study-specific documents (e.g. Safety Management Plans), and is responsible
for the creation and maintenance of the Pharmacovigilance Master File and case
files.

They are responsible for the tracking and processing of adverse events and other
safety relevant information from clinical trials and non-interventional studies (NIS)
in consideration of applicable timelines, including writing of narratives, coding and
reconciliation.

They support the creation of annual safety reports, e.g. Development Safety Update Reports.
- Screens CRF data for (serious) adverse events and other safety-related
information
- Assists in the preparation of Safety Screening Specifications (identify relevant
data points in the CRF to be screened for relevant safety events)
- Supports the preparation, maintenance and implementation of Safety
Management Plan (SMP) and other Safety-relevant documents according to
SOPs
- Performs case processing of (serious) adverse events and other safety events,
incl. data entry of safety data in the safety database and coding of safety data
(MedDRA, WHO-DD)
- Creates safety narratives for non-interventional and clinical studies
- Identifies and classifies safety events
- Reviews, analyzes, and validates (serious) adverse events and other safety
data to ensure completeness, consistency, integrity and accuracyInquiries
safety-relevant data (Safety queries) and follows up on safety events
- Creates regular safety status reports (e.g. line listings)
- Performs and manages (S)AE reconciliation
- Reviews and provides input regards to safety specific parts in documents in
non-interventional and clinical studies, e.g. CRFs or study protocols
- Electronic document management, filing and archiving in paper and
electronically, and maintenance of appropriate documentation (e.g.
Pharmacovigilance Master File, PV part of TMF, case files)
- Works according to safety related quality control processes
- Supports Medical Writing in the preparation of periodic safety reports, e.g.
DSUR
- Develops relationships with clients and is considered a junior point of contact
by clients for project requests / questions
- Prioritises workload without major input from Team Leader to ensure agreed
deadlines are met
- Develops own knowledge and personal skills in line with business
requirements
- Co-operation in further development of internal guidelines and SOPs

Education Master´s degree and 2-3 years relevant practical experience or a bachelor´s
degree and a minimum of 2-3 years of practical experience or relevant
professional education and a minimum of 4 years of practical experience or
equivalent

General Experience & Knowledge
- Highly articulate
- Sound numerical reasoning
- Highly analytical with a problem solving approach
- Careful, precise work
- Highly service-oriented
- Team player
- Good knowledge of MS Office and IT
- Very good command of spoken and written Spanish and English

Role related Experience, Knowledge & Skills
- First drug safety experience, preferably within a CRO environment
- Ability to self-organize and to multi task
- Solid analytical skills
- A good understanding of the healthcare and pharmaceutical sector
- Basic client management skills

**Detailed Description and Job Requirements**

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Entry-level position for those who are new to consulting and are developing their expertise. Receives detailed instruction on routine work and is responsible for performing basic experiments and test on research topic and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports

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