Drug Safety Officer
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Drug Safety Officer to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
Responsible 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, coordination, and documentation of all aspects of safety reporting, producing Safety Management Plans and maintaining regular contacts with the study team and sponsors. Supports PV Managers in devising new PV 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. Supports monitoring projection of hours/hours spent on projects for medical and safety activity.
- Ensure compliance and adherence to all internationally recognized standards (e.g., ICH GCP, ICH E2A etc.), national regulations and SOP’s applicable for specific 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.
- Drafts narratives per guidelines and/or individual contract agreements
- Enters relevant data from safety reports to safety database.
- Complete SAE management and safety reporting for approximately 90% of billable time.
- Work with Data Managers / Medical Directors/CRAs during the reconciliation of AE/SAE databases prior to client data delivery.
- Assure that documents are filed according to standard filing system (paper and electronic) for all contracted studies.
- Support preparation of draft Safety Management plan and review SAE Reconciliation Plans.
- Support preparation for audits and inspections by sponsors or regulatory agencies
- Track study progress, proactively identify issues and propose corrective action to the Safety Manager and PV team
- Other activities as designated
- Deputize for project Lead DSO
- 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.