Medical Safety Associate - Bratislava
- Contract Type
The Medical Safety Associate is responsible for handling safety data for including preparation and distribution of high quality Safety Reports in accordance with regulatory timelines and applicable SOP’s, planning, coordination, and documentation of all aspects of safety reporting, producing Safety Management Plans and maintaining regular contacts with the study team and sponsors. Supports monitoring projection of hours spent on projects for medical and safety activities.
We’re looking for a talented and energetic Medical Safety Associate to join our team in Bratislava, Slovakia!
Working at Premier Research means being an individual - you will be recognised 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!
In your role you will be accountable for:
Patient safety and regulatory compliance success:
Ensure compliance and adherence to all internationally recognized standards (e.g., ICH GCP, ICH E2A, ISO14155, etc), national regulations and SOP’s applicable for specific projects.
Serve as a knowledge resource for drug and/or device safety reporting issues.
Prepare draft Safety Management plan and review SAE Reconciliation Plans.
Ensure that effective safety monitoring is adhered to for all projects.
Review incoming SAEs for accuracy, completeness and potential safety issues.
Work closely with Investigator Sites/CRAs to document and clarify outstanding event issues in preparation for submitting follow-up reports.
Review all responses and confer with site staff to resolve clinical issues.
Work with Medical Monitor/ Medical Director to determine appropriate assessments with regard to relationship of event to the investigational product and regulatory reporting status of SAEs.
Draft narratives per guidelines and/or individual contract agreements.
Assure that documents are filed according to standard filing system (paper and electronic) for all contracted studies.
Work with Data Managers / Medical Directors/CRAs during the reconciliation of AE/SAE databases prior to client data delivery.
Maintain/support maintenance of safety database for specific projects.
Become the subject matter expert for the team as a Lead MSA for assigned projects/studies.
Participate in internal and external project team and client meetings.
Design and perform safety specific training to PRG employees and project team.
Support implementation and use of new technology tools.
Prepare for audits and inspections by sponsors or regulatory agencies
Represent the department and interface with other departments as needed (e.g. with data management, clinical operations, etc).
Support and deputise for the line manager/Operational Manager in managing workload and monitoring hours worked against budgeted hours.
Create training plans for new employees.
Supervise and train new employees.
Deputise for PV Managers in managing PV project activities.
High Quality Medical Support:
Provide support to Medical Directors with their Medical Monitoring activities.
Initiate medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements.
Prepare draft Medical Management plans.
Review budget and scope of medical team’s responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team.
Support Medical Directors in navigating company systems and understanding of established processes.
Track study progress, proactively resolve issues, and propose corrective action to project teams/clients.
Process and address protocol non-compliance by investigative sites and ensure adherence to ethical guidelines.
Collaborate with Medical Directors in the medical-operational aspects of complex clinical studies.
Support medical data review and discrepancy management.
Attend investigator meetings and interact with investigative site staff and client representatives.
Work closely with Investigator Sites/CRAs to document and to resolve clinical issues
Support implementation and use of new technology tools.
Prepare for audits and inspections by sponsors or regulatory agencies.
Represent the department and interface with other departments as needed (e.g. with data management, clinical operation, etc).
Ensure activities are carried out to a high standard as efficiently as possible.
Review and QC’s documents and work of other associates as needed.
Mentor other more junior members of the team.
Participate in corporate initiatives and actions that ensure the continued success of the company.
Other activities as designated.
EDUCATION, SKILLS & COMPETENCIES:
Ideally a Bachelor degree (or equivalent) or graduate in medical or related fields (e.g. medicine, nursing, pharmacy, life sciences), advanced degree preferable.
Ideally previous relevant pharma or medical related field or role. Entry level graduates in a Life Science subject may also be considered and trained in the role.
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.