At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Drug/Device Safety Officer to join our Pharmacovigilance team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you’ll be doing:

• 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

What we are searching for:

• Bachelor’s degree or graduate in medical or related fields (e.g. medicine, nursing, pharmacy, life sciences), advanced degree preferred.
• 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
• Fluent verbal and written English as well as the local language(s)
• 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 to prioritize work to meet deadlines.

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.