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 Safety Physician 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.
The Safety Physician will be serve as the safety expert accountable for pre- and post-marketing safety related deliverables such as SAE review, narrative review, AOSE, signal, benefit-risk evaluation and risk management activities for assigned study.
The Safety Physician must effectively interface cross-functionally at all levels in the organization and with external stakeholders as needed.
- Conducts medical assessment of safety related data (SAE, SUSARs, AESI etc.)
- Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure
- Provides analysis of similar events (AOSE)
- Writes safety section, including benefit risk assessment of all aggregate safety reports for regulatory submission
- Reviews Safety Management Plans
- Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) as needed for their assigned studies.
- Supports signal detection activities and risk assessment reviews
- Collaborates with Medical Directors on the safety aspects of complex clinical studies
- Works closely with other PV staff/Medical Directors/Investigative Sites/CRAs to document and assist with resolution of safety issues, e.g. SAE queries
- Reviews study documentation (e.g. budget, protocol, CRF, IB, etc.)
- Prepares for audits and inspections by sponsors or regulatory agencies
- Participates in internal and external project team and client meetings as needed
- Graduate in medicine
- Analysis of similar events - this is essential
- Signal detection desirable
- Extensive clinical practice experience in oncology, dermatology, pediatrics, or neuro-psychiatry is preferred (Board certification or equivalent not required).
- Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and GCPs and GVPs
- CRO experience is preferred
- 2 or more years’ experience of working in a medical or safety department
- Demonstrable knowledge of medical terminology and experience of handling medical data review and query resolution. Familiar with MedDRA, WHODRL and safety databases such as ARGUS and electronic data capture systems is preferred