Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.) as per the project contract
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)
Reviews Safety Management Plans
Ensures compliance with and adherence to all internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOPs applicable for specific projects
Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products.
Medical contribution to risk management activities including Risk Management Plans (RMP) and Risk Evaluation and Minimization Strategy (REMS).
Attends Investigator Meetings and interacts with Investigative site staff and client representatives as needed
Reviews study documentation (e.g. budget, protocol, CRF, IB, etc.)
Supports the Head of PV in aligning medical safety processes and procedures with the overall company PV strategy
What We Are Searching For:
Graduate in medicine
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 including FDA CFRs, EU Regulations and aligned guidance documents, EU GVP modules and ICH/ EU and FDA GCP Clinical Safety specific guidance
CRO experience is preferred
2 or more years' experience of working in a medical or safety department evaluating patient safety data
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
Be able to diagnose problems quickly and have foresight into potential issues with an aptitude in decision-making and problem-solving
Attention to accuracy, consistency and detail oriented
Ability to read, write and speak fluent English
Excellent organizational and time-management skills, able prioritize work to meet deadlines
Additional Information
Premier Research is looking for a Pharmacovigilance Physician II to join our Pharmacovigilance and Records Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · Slovakia