Research Pharmacist

Il y a 4 mois


Brussels, Belgique MindCapture Temps plein

RESEARCH PHARMACIST
- Pharma- BrusselsWHAT IS OFFERED

We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.

We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We provide personalized training to let you grow in the area of
- What you like to do
- What you are good at
- Where and how you want to have an impact

ABOUT THE COMPANY

MindCapture is a talent company specialised in medical devices, pharma and biotech. As a consultant, you will have the opportunity to learn from different environments and to be supported on a personal and professional perspective by MindCapture and our partner.

We are currently working with a global market leader within the pharmaceutical industry. You will enter a culture where ownership is an essential characteristic of every colleague. We want to excel today but also think about tomorrow and respond proactively. To achieve your work, we need each other, help each other, challenge each other and share knowledge.

As research pharmacist, you will be responsible for supporting the clinical research pharmacists in the receipt, storage, preparation and drug accountability of investigational medicinal products (IMPs) for Clinical Research Unit participants or patients, while meeting regulatory requirements for preparation of dose formulations under Good Clinical Practices (GCP) for new chemical entities (NCE) & biologicals in accordance with Good Manufacturing Practices (GMPs).

You will provide guidance en expertise in:

- Delivery of drugs, supplies and equipment required for preparation of study drugs through liaising with global teams and vendors.
- Source and procure pharmacy equipment, consumables, drugs, hazardous substances
- Arrange for supply of packaging materials, commercial available medicinal products, clinical labels
- Creation and printing of labels and other pharmacy related documents
- Receipt of IMP
- Coordinate production activities carried out by the pharmacy assistants/technicians accordingly
- Removal and preservation of reference and/or retention samples
- Cleaning of preparation material and storage once dry
- Perform accurate accountability and documentation from the point of receipt, preparation, dispensing to disposal/transfer for drugs and hazardous substances.
- Return & destruction of unused IMPs
- Labelling of materials with expiry date revisions
- Generation of the Pharmacy Product Specification File (PSF)
- Maintenance and security of randomisation codes
- Validation of aseptic processes as appropriate
- Cleaning validation of equipments as appropriate
- Investigation, documentation and notification of deviations and complaints related to IMPs
- Ensure proper handling, control, storage and disposal of drugs and hazardous substances according to Environment Health and Safety (EHS), regulatory and Pfizer requirements
- Weekly chain of custody verification activities of IMPs
- Ensure Pharmacy preparation & drug storage areas meet the EHS, GMPs and internal requirements in terms of cleanliness, temperature and humidity control, security etc.
- Ensure qualification, calibration, maintenance and cleaning of premises, instruments and equipment according to the EHS, GMPs and Pfizer requirements
- Recall of commercialized medication in Belgium used at the PCRU
- Administrative follow up and filing of pharmacy clinical studies documents in the relevant internal repository
- Follow up of orders and general stock (emergency cart products, non-study drugs, emergency medicine, etc)
- Escort and assistance to external vendors (for maintenance, repair, etc) during their presence onsite
- Assure compliance with internal Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

REQUIRED COMPETENCES & SKILLS
- You have a pharmacist master’s degree (Titulaire du titre de Pharmacien)
- Fluent in French and English. Dutch is a strong plus.
- Experience in pharmacy industry is a nice to have.
- Experience as pharmacien d’officine or experience in a hospital is sufficient.
- Experience in dose preparation and Quality control in retail/hospital pharmacy is an asset.
- Knowledge of Good Clinical Practices and Good Manufacturing Practices is an asset.


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