Madrigal Pharmaceuticals
Senior Manager, Postmarketing Pharmacovigilance
Madrigal Pharmaceuticals, Conshohocken, Pennsylvania, United States, 19428
Reporting to the Associate Director, Postmarketing Pharmacovigilance or higher, the Senior Manager, Postmarketing Pharmacovigilance will play a key role in supporting the safety assessment, evaluation, and risk management of products in the postmarketing setting, including involvement in safety surveillance activities.Position Responsibilities: Ensure Postmarketing reporting process is efficient and compliant with reporting requirements and as detailed in the Safety Management Plan.Collaborate within pharmacovigilance team on work activities regarding safety signals, analysis and safety data summaries.
Assist with data collection for safety inquiry responsesAssist with data collection for development of safety content for relevant safety documents or sections.Review safety database data listings, as assigned, for inconsistencies and summarize draft queries as appropriateReview relevant study documents for safety-related information for assigned projects (e.g., registry protocols, Safety Management Plan, SAE Reconciliation Plan, etc.)Support review of postmarketing data for SRT reviewCoordinate scheduling of SRT, including collation and distribution of meeting materials and setting of agendaSupport aggregate report deliverablesAssist with data collection as needed to support labeling activitiesAssist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety informationOversee monthly reconciliation process performed by PV vendorSupport team review of regulatory safety documents for assigned projects, e.g., Periodic Risk Benefit EvaluationReports (PBRERs), Periodic Adverse Drug Evaluation Report (PADER) and Risk Management Plan(s) (RMPs)Review ICSRs (including case narratives, causality assessments and coding) for assigned projectsInterface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasks.
Liaise with PV vendor to coordinate updates to relevant plansAssist with other PV compliance activities as required.
Create and/or maintain relevant departmental documents such as expectedness list and coding conventionsPerform additional tasks as instructedQualifications and Skills:Bachelor’s degree in relevant scientific discipline.
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
Clinical experience (e.g.
RN, BSN, or PharmD) is preferred, but not requiredDrug Safety professional with minimum 6 to 8 years of direct experience within drug safety and PV, inclusive of case quality control and regulatory submissions of ICSRs worldwideAbility to interpret health and medical records such as adverse event reporting forms, discharge summary, etc.Experience with safety databases; Argus is a plus but not mandatoryGood knowledge of pharmacovigilance reporting rules and timelinesGood knowledge of ICH E2B(R2) and (R3) specifications and entry guidanceExperience with clinical case processing, including MedDRA and WHO Drug coding and narrative writingExperience in managing external teams preferredExcellent in detailed-oriented tasksExcellent written and verbal communication skillsCompensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands.
The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.SummaryLocation: Conshohocken, PA, United StatesType: Full TimeExperience: Senior Manager/SupervisorDepartment: Pharmacovigilance
Assist with data collection for safety inquiry responsesAssist with data collection for development of safety content for relevant safety documents or sections.Review safety database data listings, as assigned, for inconsistencies and summarize draft queries as appropriateReview relevant study documents for safety-related information for assigned projects (e.g., registry protocols, Safety Management Plan, SAE Reconciliation Plan, etc.)Support review of postmarketing data for SRT reviewCoordinate scheduling of SRT, including collation and distribution of meeting materials and setting of agendaSupport aggregate report deliverablesAssist with data collection as needed to support labeling activitiesAssist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety informationOversee monthly reconciliation process performed by PV vendorSupport team review of regulatory safety documents for assigned projects, e.g., Periodic Risk Benefit EvaluationReports (PBRERs), Periodic Adverse Drug Evaluation Report (PADER) and Risk Management Plan(s) (RMPs)Review ICSRs (including case narratives, causality assessments and coding) for assigned projectsInterface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasks.
Liaise with PV vendor to coordinate updates to relevant plansAssist with other PV compliance activities as required.
Create and/or maintain relevant departmental documents such as expectedness list and coding conventionsPerform additional tasks as instructedQualifications and Skills:Bachelor’s degree in relevant scientific discipline.
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
Clinical experience (e.g.
RN, BSN, or PharmD) is preferred, but not requiredDrug Safety professional with minimum 6 to 8 years of direct experience within drug safety and PV, inclusive of case quality control and regulatory submissions of ICSRs worldwideAbility to interpret health and medical records such as adverse event reporting forms, discharge summary, etc.Experience with safety databases; Argus is a plus but not mandatoryGood knowledge of pharmacovigilance reporting rules and timelinesGood knowledge of ICH E2B(R2) and (R3) specifications and entry guidanceExperience with clinical case processing, including MedDRA and WHO Drug coding and narrative writingExperience in managing external teams preferredExcellent in detailed-oriented tasksExcellent written and verbal communication skillsCompensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands.
The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.SummaryLocation: Conshohocken, PA, United StatesType: Full TimeExperience: Senior Manager/SupervisorDepartment: Pharmacovigilance