Safety Scientist Medior - Genappe, België - Keyrus Life Science Belgium

Keyrus Life Science Belgium

Geverifieerd bedrijf

Genappe, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

What we offer
Joining our consulting team in Belgium means giving your career a step forward.

Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager.

We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth.

On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization ) based on your background and experience.

Keyrus Life Science is looking for a
Safety Scientist Medior to join our consulting team for a client project based in
Wavre (Belgium).

Your challenges will be:

To provide* toxicological expertise and support
for Global manufacturing *and Global Quality for all matters related to quality issues in manufacturing (e.g.

residuals, contaminants, E&L, raw mats, PIRCs, intelligence re:
vaccine/adjuvant quality standards and regulations).

Direct
risk assessment for patient safety.
Conducting* literature searches* for nonclinical toxicology and safety information.
Maintaining a
toxicological database for residuals and contaminants.
Following up on
inquiries from the client and Global QA (for example provision of expert toxicological advice for deviations, extractables & leachable and other manufacturing quality issues).
Complementing the toxicological investigations by
Clinical Safety assessments when applicable.
Interacting with
Global Quality, Global RA and other Safety groups to acquire expertise necessary to perform the job and to facilitate integrated assessments.
Providing
support to the team in their routine and adhoc activities such as data management and signal detection and evaluation).

-
Improve process for the patient safety and toxicology risk assessment of GMP.

Profile
-
Master of Sciences or
PhD in Pharmacy/Toxicology or related areas

At least
3 years fulltime experience in a Pharma company, working in
Quality,
Drug Safety, or
Regulatory affairs or other where evaluations related to patient safety were part of the activities performed.
Familiarity with standard methodologies related to
Good Manufacturing Practices (GMP) or
Good Pharmacovigilance Practices (GCP).
Demonstrated ability to think critically and innovatively, identify and solve problems.
Influencing/Persuasion skills.
Proven ability to interact well in a multifunctional team setting.
Commitment to continuous improvement.
Excellent communication skills.
Fluent written and spoken English.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.

Our 'human' approach to service provision is what differentiates us from our competitors. Combined with our high calibre staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we're proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients' projects, priorities and reputation.

Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.