Drug Device Safety Officer
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a Drug/Device Safety Officer to join our team! This is a permanent role to be located in our office in Bratislava, Slovakia. This is an ideal opportunity for someone looking to start their career in Clinical Research. You will be assigned a mentor in Slovakia and will have support from an experienced team and line manager.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
You’ll be accountable for:
- Handling safety data for specific projects including preparation and distribution of high quality Safety Reports in accordance with regulatory timelines and applicable SOP’s
- Planning, coordinating, and documenting all aspects of safety reporting
- Producing Safety Management Plans and maintaining regular contacts with the study team and sponsors
- Supporting Drug Safety Managers in devising new Pharmacovigilance / Drug Safety processes and Medical Monitors with monitoring activities of specific projects including study startup/setup, contact with sites and internal teams, processing and review of clinical investigation results, medical data review and projecting
- Supporting monitoring projection of hours/hours spent on projects for medical and safety activity
- Ensuring compliance and adherence to all internationally recognized standards (e.g., ICH GCP, ICH E2A etc.), national regulations and SOP’s applicable for specific projects
- Reviewing incoming Serious Adverse Event (SAEs) for accuracy, completeness and potential safety issues
- Working closely with Investigator Sites/CRAs to document and clarify outstanding event issues in preparation for submitting follow-up reports
- Drafting narratives per guidelines and/or individual contract agreements
- Entering relevant data from safety reports to safety database
- Completing Serious Adverse Event management and safety reporting for approximately 90% of billable time
- Working with Data Managers / Medical Directors/CRAs during the reconciliation of AE/SAE databases prior to client data delivery
- Assuring that documents are filed according to standard filing system (paper and electronic) for all contracted studies
- Supporting preparation of draft Safety Management plan and review SAE Reconciliation Plans
- Supporting preparation for audits and inspections by sponsors or regulatory agencies
- Tracking study progress, proactively identify issues and propose corrective action to the Safety Manager and Pharmacovigilance / Drug Safety team
- Other activities as designated
- Deputize for project Lead Drug Safety Officer
You'll need this to be considered:
- Bachelor degree or graduate in medical or related fields (e.g. medicine, nursing, pharmacy, life sciences), advanced degree preferable.
- 0-2 years in a relevant pharma or medical related field or role eg. CRA, Pharmacy etc.
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / ISO 14155 standard, drug / device development, and clinical monitoring procedures
- Knowledge of web based communication tools for conferences
- Fluent verbal and written English as well as the local language(s)
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication and negotiation skills.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines.
- Accountable, dependable and strong commitment.
- Is customer service focused in approach to work both internally and externally
- Maintains a positive, results orientated work environment