Job Description

Medical Reviewer is the key contact person for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables, including both early and late-stage development, as assigned. He/she is accountable for safety and risk management activities for one or more assigned products. He/she will manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned product(s). The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. ESSENTIAL DUTIES AND RESPONSIBILITIES: Analyzes, reviews, and interprets safety data, both non-clinical and clinical. Performs medical review of ICSRs, and other drug safety information from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate and literature reports. Provides technical and medical expertise in medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes. Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements. Contributes to the development of Standard Operating Procedures, Working Instructions and other guidance documents. Contributes to safety and pharmacovigilance training programs. Provides safety training at investigator meetings. Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services. Training and mentoring of Pharmacovigilance Physicians and Specialists. Demonstrates knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, FDA, PMDA, EMA, ICH, etc.). EDUCATION AND EXPERIENCE REQUIRED: 1-3 years experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable. Medical Degree (MBBS or higher) from recognized medical school. PREFERRED SKILLS: Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines. Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities. Proficiency with medical review of ICSRs, including coding and use of SMQs, expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment. Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment). Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders. Excellent verbal, written and presentation skills. Innovative, collaborative, initiative-taker.

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