[Hiring] Pharmacovigilance Physician II @Premier Research

Role Description

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.

What You'll Be Doing:

• 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).
• Writes safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
• 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.

Qualifications

• 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 to prioritize work to meet deadlines.