Clinical Safety Associate
A midsized full service European Contract Research Organization seeks experienced individuals from the pharmaceutical industry or clinical/medical settings, but also successful university graduates who are willing to enter a steep learning curve, for the position of
Clinical Safety Associate
to follow up on safety surveillance activities and medical input for our clinical operations.
Location: Novi Sad, Serbia
Responsibilities (including but not limited to):
- Conduct all pharmacovigilance activities in compliance with regulatory guidelines and local SOPs
- Processing of safety reports (Serious Adverse Events, pregnancy, overdose, study specific findings/alerts) by reviewing reports, writing narrative, creating medical queries, tracking the events
- Expedited reporting (SUSAR, DSUR) to regulatory authorities and ethics committees across the European countries
- Development, periodic review and update of the study specific Safety and Medical Management Plans, together with creation of safety reporting forms
- Presenting project specific training on medical topics and safety reporting to the clinical project team
- Assisting in development and revision of company’s SOPs, mainly for Drug Safety Unit
- Providing medical input during development of study specific documents such as Protocol, Investigator Drug Brochure, Patient Informed Consent, CRF, CRF Completion Guideline, Work Specific Instructions
- Attendance to relevant project meetings and teleconferences, with providing the update on the safety events throughout the course of the clinical trial
- Maintaining good and professional relationship with other company department, liaison with clinical trial Sponsors, laboratory representatives, external medical experts
- Assessing eligibility of the patients in close collaboration with Investigator and Sponsor
- Providing medical recommendations to the investigators with respect to the issues raised during the particular study
- Acquire and maintain current medical knowledge of applicable indications for which the relevant treatments are being investigated
- Responsible for oversight of Core Safety Reporting File
Qualifications:
Education and Work Experience:
- Medical Doctor degree. Master degree or specialization is an asset
- Experience in clinical trials as well as knowledge of GCP and ICH guidelines preferred
Knowledge, Skills, and Abilities:
- Excellent interpersonal verbal and written communication skills
- Fluent in English, written and spoken
- Strong computer literacy (MS Word, Excel and PowerPoint)
- Good organizational, record retention and time management skills
- Demonstrating positive professional behavior, punctuality, consistently meeting timelines and following up without being prompted
We offer creative, collaborative, dynamic and pleasant working international environment, giving each and every associate a significant change to emerge. You will work with international clients, with leaders in biotechnology, and with top level healthcare professionals, leading clinical investigators. Through diverse project work, we allow employees to grow professionally, to identify their particular interests and develop their team-working skills and careers within the scope of company operations.
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