Manager, PVRM

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work collaboratively with cross-functional colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential.

Job Duties and Responsibilities

• Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
• Assist in signal detection activities including data assembly, signal validation, and signal evaluation.
• Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities.
• Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.)
• Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings.
• Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required.
• Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results.
• Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
• Collaborate with Clinical Development to interpret safety data from ongoing clinical trials.
• Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program.

• Support collaboration with external partners

Key Core Competencies

• Strong understanding of pharmacovigilance regulations and drug safety reporting requirements
• Skills in signal detection, risk assessment, and safety data analysis
• Proficiency with safety databases and software
• Ability to evaluate and write case reports and prepare regulatory submissions
• Analytical thinking and attention to detail
• Communication skills for cross-functional collaboration and regulatory interactions
• Project management and organizational abilities
• Ability to work effectively within teams
• Additionally, experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable for this position

Education and Experience

• Minimum of bachelor’s level degree in a health care/life science related field, with Master’s or other graduate degree preferred.
• Minimum 3 years’ experience within Pharmacovigilance and in the pharmaceutical industry.
• Prior experience in oncology, and/or neurology is strongly preferred.
• Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products.

The base salary range for this role is $127,920 to $159,900. 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.

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 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.