Sumitomo Pharma
Associate Medical Director, PVRM
Sumitomo Pharma, Little Rock, Arkansas, United States, 72208
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of
Associate Medical Director . The Associate Medical Director will provide hands-on PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle including signal detection, signal validation, signal escalation, development of risk mitigation strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. Responsibilities
Continuous monitoring and ongoing risk/benefit assessment for assigned investigational and marketed products.
Conduct safety surveillance over product life cycle, reviewing clinical trial and postmarketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs).
Contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data.
Generates safety queries, evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators Brochures (IB), Investigator communications (Dear Health Care Provider letters - DHCP), Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), Company Core Data Sheets (CCDS), Locally approved labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM).
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements.
Contributes to Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS).
Contributes to PVRM and cross-functional drug development teams and manages Safety Charters.
Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries.
Represents PVRM on post-marketing product specific and/or clinical study team meetings and governance committees.
Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk benefit management, and development of risk mitigation strategies.
Ensure timely submission of periodic aggregate ADR reporting for clinical trials and post-marketing experience as required by local and global regulations.
Participates/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, audits, and inspections.
Prepares and presents safety information (i.e. safety graphs, tables, and reports) to project teams and senior management, pertaining to the safety profile of therapeutically assigned compounds/products.
Reviews and updates PVRM Standard Operating Procedures and process enhancements as needed.
Manages PVRM external vendors Medical PV operations group.
Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of Safety First in line with SMPAs values and related behaviors.
Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance.
Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster/nurture teamwork, and act as a facilitator to drive fulfillment of strategic goals.
Willingness to be very hands-on in a fast-paced work environment, and ability to reprioritize as needed.
Strong communication skills with excellent written and spoken English.
Education and Experience
Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company
Experience in Oncology and Neurology is preferred
Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and postmarketing US FDA and/or EU ICH safety requirements
Expertise in medical review of Individual case safety reports and aggregate safety reports
Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements
Experience managing safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer The base salary range for this role is $180,400 to $225,500. Base salary is part of our total rewards package which also includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our flexible time-off policy includes paid time off, holidays, and sick time as applicable. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Confidential Data
: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance
: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements
: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgement as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer #J-18808-Ljbffr
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of
Associate Medical Director . The Associate Medical Director will provide hands-on PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle including signal detection, signal validation, signal escalation, development of risk mitigation strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. Responsibilities
Continuous monitoring and ongoing risk/benefit assessment for assigned investigational and marketed products.
Conduct safety surveillance over product life cycle, reviewing clinical trial and postmarketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs).
Contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data.
Generates safety queries, evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators Brochures (IB), Investigator communications (Dear Health Care Provider letters - DHCP), Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), Company Core Data Sheets (CCDS), Locally approved labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM).
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements.
Contributes to Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS).
Contributes to PVRM and cross-functional drug development teams and manages Safety Charters.
Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries.
Represents PVRM on post-marketing product specific and/or clinical study team meetings and governance committees.
Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk benefit management, and development of risk mitigation strategies.
Ensure timely submission of periodic aggregate ADR reporting for clinical trials and post-marketing experience as required by local and global regulations.
Participates/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, audits, and inspections.
Prepares and presents safety information (i.e. safety graphs, tables, and reports) to project teams and senior management, pertaining to the safety profile of therapeutically assigned compounds/products.
Reviews and updates PVRM Standard Operating Procedures and process enhancements as needed.
Manages PVRM external vendors Medical PV operations group.
Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of Safety First in line with SMPAs values and related behaviors.
Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance.
Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster/nurture teamwork, and act as a facilitator to drive fulfillment of strategic goals.
Willingness to be very hands-on in a fast-paced work environment, and ability to reprioritize as needed.
Strong communication skills with excellent written and spoken English.
Education and Experience
Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company
Experience in Oncology and Neurology is preferred
Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and postmarketing US FDA and/or EU ICH safety requirements
Expertise in medical review of Individual case safety reports and aggregate safety reports
Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements
Experience managing safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer The base salary range for this role is $180,400 to $225,500. Base salary is part of our total rewards package which also includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our flexible time-off policy includes paid time off, holidays, and sick time as applicable. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Confidential Data
: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance
: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements
: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgement as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer #J-18808-Ljbffr