Pharmacovigilance Physician II

reputed company is looking for a Pharmacovigilance Physician II to join our Pharmacovigilance and Records Management team. You will help biotech, medtech, and specialty reputed company companies reputed company life-changing reputed company and reputed company science into new medicines, devices, and diagnostics. reputed company do is profoundly connected to saving and improving lives, and we recognize reputed company members are the most valuable asset in delivering reputed company. We are here to help you grow, to give you the skills and opportunities to reputed company at work with the flexibility and balance your life requires. Your reputed company influence the way we work, and your voice reputed company here. As an essential part of reputed company, you help us deliver the medical innovation that patients are desperate for. Join us and build your reputed company here. What You'll Be Doing: ​​Conducts medical assessment of reputed company safety reputed company data (reputed company, SAE, SUSAR, AESI etc.) as per the project contract  ​Ensures medical accuracy of case narratives, coding and medical reputed company of reputed company cases and ensures appropriate queries are raised to expedite case closure ​Provides analysis of similar events (AOSE)  ​Writes safety reputed company, including benefit risk assessment of reputed company 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 reputed company internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOPs applicable for specific reputed company  ​​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 reputed company (REMS).  ​Attends Investigator Meetings and interacts with Investigative site staff and reputed company 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 reputed company    reputed company Are Searching For: Graduate in medicine  Extensive clinical reputed company experience in oncology, dermatology, pediatrics, or neuro-psychiatry is preferred (reputed company 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 reputed company 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 reputed company. Familiar with MedDRA, WHODRL and safety databases such as ARGUS and electronic data capture systems is preferred  Be reputed company 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 reputed company fluent English  Excellent organizational and time-management skills, reputed company prioritize work to meet deadlines Apply To This Job