1+ months

Clinical Research Pharmacist

Anderlecht, Brussel 1070
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Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies).

**JOB RESPONSIBILITIES** **1. Qualified Person**

+ Meets the permanent provisions of Directive 2001/83/EC (Articles 48,49 and 51)

+ Acts as a Brussels PCRU Pharmacy Qualified Person for the Release of clinical materials manufactured and packaged at the Brussels PCRU

+ Ensures that each batch of IMP that is made within the EU meets the requirements of GMP and the Clinical Trial Application (CTA)

+ Ensures that for an IMP made in a third country, each batch meets the requirements at least equivalent to those in the EU, and the CTA requirements

+ Ensures that for a comparator from a third country, if documents are not available to show that it was made in accordance with EU GMP, that it has had all the analyses, test or check necessary to confirm its quality in accordance with the CTA

+ Facilitates the smooth transition through the regulatory process for QP release

+ Certifies in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51

+ Takes part in investigations into cGMP system failures

+ Maintains knowledge of cGMP and future/proposed changes

+ Keeps up to date with current regulatory guidance and expectations

**2. Research Pharmacy activities**

+ Coordinate timely delivery of drugs, supplies and equipment required for preparation of study drugs through liaising with Pharmaceutical Sciences colleagues and vendors.

+ Perform accurate accountability and documentation from the point of receipt, preparation, dispensing to disposal/ transfer for drugs and hazardous substances.

+ Responsible for manufacturing, dispensing, reconstitution, packaging and labelling of individual subject doses in accordance with preparation instructions

+ Storage and Quality check of individual subject doses

+ QP Release and batch certification of individual subject doses

+ QA review of individual subject doses

+ Return unused IMPs and/or arrange for destruction of unused/returned IMPs

+ Removal and preservation of reference and/ or retention samples

+ Arrange for supply of packaging materials, commercial available medicinal products, clinical labels

+ Responsible for development, maintenance and approval of preparation and packaging instructions

+ Create instructions as appropriate for dispensing of IMP and instructions for preparation of commercial drug supply

+ 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 IMP to the Pharmacy&Regulatory Director and as appropriate to PharmSci QA, Quality Compliance Manager and Site Lead.

+ Storage of executed instructions and associated documents

+ Ensure proper handling, control, storage and disposal of drugs and hazardous substances according to EHS, regulatory and Pfizer requirements

+ Ensure Pharmacy Operations & drug storage areas meet the EHS, regulatory and Pfizer 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, regulatory and Pfizer requirements

+ Review and provide professional input for study related documents such as the study protocol, informed consent document, extemporaneous dispensing record (EDR), dosing administration instruction (DAI), Investigational Product Manual (IP manual) and clinical supplies agreement (CSA)

+ Source and procure pharmacy equipment, consumables, drugs, hazardous substances

+ Perform study drug setup & QC and QC of dosing events

+ Ensure that essential pharmacy related documents are filed into the ISF and uploaded into eTMF

+ Provide training to peers for assistance in carrying out complex tasks

+ On-site recall duty 24/7 for need or urgency

+ Participate and contribute feedback within and across PCRU teams.

+ May act as SME responsible for SOP updates and review within the function

+ Participate actively to the Self-inspection program of the Research Pharmacy Operations

**3. Regulatory activities**

+ Have a complete understanding of all regulatory required documents

+ Ensure that clinical trials are conducted in accordance with scientific, medical and ethical principles & within regulatory requirements/guidelines.

+ Secure all necessary regulatory approvals and licences for clinical trial conduct, import, storage, preparation & dispensing of drugs and hazardous substances in the PCRU

+ Compile the Clinical Trial Application (CTA) package in colaboration with Regulatory department, RegCMC manager and WW Research & Dev colleagues to ensure timely and accurate submission of studies to Competent Authorities (CA) and responses to queries from Regulatory Authorities in a timely manner for IMP/IMPD related matters

+ Is responsible for the preparation and approval of the Investigator Initiation Package (IIP) under the local IIP approval program for studies conducted at the Brussels PCRU

**4. Training**

+ Participate in training courses as appropriate

+ Assist in the training of PCRU staff and contractors with less experience and expertise


+ Advanced Master Degree (Postgraduate Degree) in Industry Pharmacy

+ Experienced Qualified Person (QP) with QP Certification number recognized in Belgium

+ Evidence of continuing education/training relative to Pharmaceutical Industry and QP role

+ Experience: ideally 4 to 8 years experience in pharmaceutical industry

+ Phase I experience is an important asset; other pharmaceutical experience is an asset.

+ Very good knowledge of English and good command of French/Dutch

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-05-20 Expires: 2019-07-20

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Clinical Research Pharmacist

Anderlecht, Brussel 1070

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