Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)

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.

Job Duties and 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 post–marketing 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), Investigator’s 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 vendor’s 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 -SMPA’s 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 is highly desired
• Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and post–marketing US FDA and/or EU ICH safety requirements
• Expertise in medical review of 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.

The base salary range for this role is $155,040 to $193,800. Base salary is part of our total rewards package which also includes the opportunity for 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 robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

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 "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment 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

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.