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 crossfunctional collaboration The position also contributes to new business initiatives by offering medical expertise and supporting SME onboarding Strong pharmacovigilance knowledge problemsolving ability and a proactive qualitydriven 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 teamDevelop materials slides etc for Safety Management Team SMT Pharmacovigilance committee PVC or Safety Data Review meetings and provide input into recommended safety actionsOversee 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 meetingsServes as the Lead for several compounds and oversees the operational execution of all safety related clinical trial activitiesProvides support in the strategy and authoring of integrated submission documentsProvide medical expertise for clinical protocol development and medical monitoring of clinical trialsCreation 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 Investigators Brochures Aggregate Safety Reports PSUR DSUR Annual Reports Standard Risk Language for ICFs Company Core Data Sheet and Risk Management PlansOversees studylevel activities as needed generation of ICSR safety sections of the protocols Clinical Study Reports risk benefit assessment for EU CTAs protocol CRF review ICFSupervises trains and mentors junior safety scientists and or other safety staffLeads various process improvement and crossfunctional initiatives for pharmacovigilance including QA related documents Provide pharmacovigilance strategic advice and medical writingBusiness development as directedBoard 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 experienceExperience 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 postmarketing 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 problemsolving skills Robust computer skills with working knowledge of Microsoft Outlook Excel Word and PowerPoint

📌 Lead Medical Reviewer (Sahibzada Ajit Singh Nagar)
🏢 EVERSANA
📍 Sahibzada Ajit Singh Nagar