THE POSITION: The Medical Review Lead (MRL) is responsible for supporting the timely and compliant execution of product surveillance activities for client projects. The role involves oversight and contribution to aggregate reports (PADERs, PBRERs), Risk Management Plans (RMPs), signal detection, PLLR, and annual literature reviews, ensuring alignment with regulatory requirements. The MRL serves as a Subject Matter Expert (SME) in medical review and ICSR management, providing scientific inputs, performing quality review, authoring key sections of PV documents, and addressing regulatory queries. Additionally, the role supports project management activities, documentation, and cross-functional collaboration. The position also contributes to new business initiatives by offering medical expertise and supporting SME onboarding. Strong pharmacovigilance knowledge, problem-solving ability, and a proactive, quality-driven approach are essential for success in this role.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams.
These results are achieved by:
• Provides support to line managers in activities relating to management of medical review team
• Develop materials (slides, etc.) for Safety Management Team (SMT)/Pharmacovigilance committee (PVC) or Safety Data Review meetings and provide input into recommended safety actions
• Oversee the adjudication and analysis of signal detection outputs, quality assurance of synthesized key safety information; development and continuous improvement of signal detection evaluation and tracking tool
• Lead signal management and benefit risk evaluation (i.e., PBRER) • Provide medical and pharmacovigilance leadership at safety leadership meetings
• Serves as the Lead for several compounds and oversees the operational execution of all safety- related clinical trial activities
• Provides support in the strategy and authoring of integrated submission documents
• Provide medical expertise for clinical protocol development and medical monitoring of clinical trials
• Creation of the safety section in protocols, informed consents, reference safety information and periodic reports (i.e. DSUR)
• Authors or oversees development of content for safety sections of documents such as Investigator’s Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans
• Oversees study-level activities (as needed): generation of ICSR, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
• Supervises, trains and mentor’s junior safety scientists and/or other safety staff
• Leads various process improvement and cross-functional initiatives for pharmacovigilance including QA related documents. Provide pharmacovigilance strategic advice and medical writing
• Business development as directed
• Board certified Physician with clinical experience of at least 2 years.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
• All other duties as assigned.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
Education: MD or MBBS
• Experience and/or Training: 7 years’ pharmacovigilance experience
• Experience in the clinical and drug development process in a pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information.
• Knowledge of and ability to interpret and apply international safety regulations and develop processes or advise clients on developing and implementing this process.
• Experience in preparing and implementing product surveillance and risk management requirements such as investigational and post-marketing regulatory reports. Experience developing data analysis and medical evaluation of safety data and proposing safety actions for products from the data.
• Experience with pharmacovigilance related to computer systems and programs, provide inputs for the safety system implementation. Experience managing people and teams are preferred.
• Excellent leadership skills and Willingness to mentor others. Detail oriented.
• Excellent interpersonal and organizational skills. Excellent written and verbal communication skills.
• Ability to work proactively.
• Excellent problem-solving skills.
• Strong computer skills with working knowledge of Microsoft Outlook, Excel, Word and PowerPoint
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