Research Pharmacist
Research Pharmacist
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Location/Division Specific Information
Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compounds clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover they set the stage for subsequent studies that will ultimately determine your compounds efficacy safety and positive impact on patients lives.
Discover Impactful Work:
Accountable for all study investigational medical product (IMP) including oversight of the receiptdispensing and return of used/unused IMP ensuring correct storage complying with company SOPs andCOPs and identifying opportunities for process improvement. Consistently serves as a source of clinicalexpertise to investigators clinic and support staff client services sponsors and others as needed. Incoordination with departmental management team coordinates interdepartmental communicationssupports departmental training and adherence to regulatory educational requirements as well assupports departmental QA/QC functions.
A day in the Life:
- Dispenses IMP on all studies according to local regulations sponsor writteninstructions and SOPs.
- Provides training to patients on self-administrating of IMP.
- Oversees all study IMP and maintains accountability logs per study/sponsorrequirements.
- Serves as pharmacy lead on incoming clinical study protocols; plans andprepares for accurate dosing including packaging preparation andadministration of doses.
- Ensures adequate supplies of clinical samples are retained with documentation ofrandom selection procedure as required for study.
- Serves as liaison and consultant to sponsors concerning pharmacy details forfuture and current protocols.
- Interacts as a vital member of the site team offering guidance on pharmacyprocedures and operations specific to each protocol.
- Serves as departmental resource for pharmacy-related clinical inquiries frominvestigators clinic and support staff client services sponsor companies andothers as needed.
- Participates in cross-training activities with other departments.
- Collaborates with management on improving department processes and
- procedures.
- Ensures adherence to corporate procurement procedures.
- Ensures correct storage of IMP on each study and maintains temperature logs inthe dispensary. Manages temperature excursions and reports thereof as persponsors written instructions and internal SOPs.
- Oversees the safekeeping of code break envelopes.
- Returns used and unused IMP to the sponsor/depot as per written instructions.
Keys to Success:
Education and Experience
- Bachelors degree in Pharmacy or Pharm D degree
- Must hold a valid pharmacy licence within the country operating. Must be registered with local health careauthority.
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to8 years).
Knowledge Skills Abilities
- Expert knowledge of important regulatory considerations
- Proven ability to assess the safety and tolerability of different classes of drugs
- Expert knowledge of the drug development process and familiarity with guidelines for marketingauthorization submissions and international guidelines for conduct of clinical studies
- Demonstrated ability to work independently analyze and work with attention to detail processingand prioritizing sensitive and complex information and problem solving
- Advanced analytical ability
- Demonstrated ability to exercise discretion and sound judgement
- Effective strong decision-making negotiation and influencing skills
- Excellent organizational skills and detail-orientated leadership approach
- Proficiency in basic computer applications
- Effective interpersonal skills to work in a team environment
- Excellent communication skills with Czech and English
Employment Type
Part-Time
