Medical Reviewer - ICSR

Job description

Medical Reviewer-Drug Safety Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Medical Reviewer Location : Mysore-Hybrid 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. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Permanent, Full Time COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.