Job Overview
The Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical safety aspects of clinical trials, including the review and addressing of safety queries related to protocols, informed consent forms (ICF), safety management plans (SMP), clinical study reports (CSR), and investigator brochures (IB). The role also involves the medical review and assessment of individual case safety reports (ICSRs), providing expertise in the review and approval of aggregate safety reports such as PSUR, PBRER, DSUR, PADER, company core data sheets, local approved labels, RMP/REMS, regulatory inquiries, and health hazard assessments. The incumbent will support safety signal management throughout the product lifecycle, develop risk mitigation strategies, author signal evaluation reports, and communicate safety issues to senior leadership. The position reports to the VP, PVRM and Global Pharmacovigilance Head.

Responsibilities

• Lead safety strategy and key messaging in NDA/BLA/MAA submissions

• Lead ongoing safety monitoring of assigned investigational and marketed products

• Provide PVRM medical representation on product-specific and/or clinical study team meetings and governance committees

• Prepare and present safety data analysis to project teams and senior management for assigned products

• Evaluate safety data and author safety sections as a medical safety subject matter expert on study protocols, ICFs, SMPs, CSRs, and IBs

• Contribute to the preparation and update of company core data sheets, USPI, SmPC, PM, RMPs/REMS

• Medical review of aggregate reports (PADER, PSUR, PBRER, DSUR, IND/NDA annual reports)

• Handle health hazard evaluations and ad‑hoc regulatory safety inquiries

• Perform aggregate safety data reviews supporting signal detection, trend analysis, risk/benefit management, and other departmental activities

• Participate in literature evaluation, investigator site training, internal staff continuing education, audits, and inspections

• Develop and maintain strong relationships with cross‑functional teams such as Clinical Development, pre‑clinical Safety, Clinical Operations, and Clinical Pharmacology

• Maintain a working knowledge of applicable global regulatory authority regulations

• Support PVRM or cross‑functional ad‑hoc projects requiring safety input

• Ensure compliance with regulations/internal SOPs and foster a culture of “Patient first” in line with SMPA’s values

• Ensure timely and quality review of ICSPRs, including seriousness, expectedness, narrative quality, adverse event coding, concomitant medication coding, and causality statements

Key Core Competencies

• Thorough knowledge of the pharma industry, clinical research, and global regulatory requirements, including expedited and periodic safety reporting, signal generation, safety evaluation, and risk management strategies

• Thorough knowledge of FDA and ICH safety reporting regulations and guidelines

• Strategic and critical thinking with strong oral and written communication skills

• Team‑oriented interpersonal skills and ability to lead directly or indirectly with influence

• Strong problem‑solving, conflict resolution, and analytical skills

• Ability to travel domestically and internationally as required

• Demonstrated coaching skills to develop a team

• High degree of organizational awareness and ability to connect interdependencies and the big picture

Education and Experience

• Medical Degree (MD) with 12+ years of relevant experience in the biotech or pharmaceutical industry

• Experience in Oncology and Neurology is preferred

• Experience with NDA/BLA/MAA submission

• Prior people‑management experience

Base Salary Range

$288,200.00 – $360,200.00

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, in accordance with applicable law.

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.

Travel Requirements

Primarily remote role with periodic on‑site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements

Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre‑employment drug test.

Equal Employment Opportunity (EEO) Statement

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, 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.