Product Safety & Pharmacovigilance Manager

The Product Safety & Pharmacovigilance (PSPV) Manager is responsible for overseeing and managing the PSPV team, ensuring efficient case processing, safety information management in clinical trials, compliance with corrective and preventive actions (CAPA), audit and inspection correspondence, team training and development, and collaboration with internal and external stakeholders to maintain product safety and regulatory adherence.

• Manage activities of CROs, vendors, and temporary staff performing PV operations; provide direction, oversight, and feedback to ensure adherence to quality and compliance standards.
• Oversee and guide case processing activities to ensure the effective monitoring and evaluation of SHIONOGI product safety information, while maintaining compliance with regulatory requirements.
• Oversee PV system to ensure compliance of employees, partners and distributors.
• Maintain safety databases (e.g., Argus, ArisG) and ensure data accuracy and compliance.

• Ensure the ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids, aligning them with current local and global pharmacovigilance processes, guidelines, and regulatory requirements.
• Ensure PV operation continuity including but not limited to the maintenance of the process or disaster recovery plan of Safety Database.
• Supervise and manage preparation and submission of the aggregate reporting in accordance with applicable regulations.
• Maintain the training matrix in PSPV team and lead the trainings of PSPV members or new hire and the company PV training for SI employees.

• Oversee the preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
• Manage the pharmacovigilance agreements or safety clause in the contracts with partners or contract research organizations.
• Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV.
• Perform other duties as required.
• Other Duties as needed.

Minimum Job Requirements

Qualifications/Experience

• Bachelor’s degree in pharmacy or nursing (BSN/RN) required.
• Minimum of 5 years in Drug Safety/Pharmacovigilance in the pharmaceutical industry; Previous experience with safety database programs; i.e., Argus, Aris-G, etc. desired
• Applied knowledge of global regulations and global compliance timeline desired.
• Requires an understanding of regulations relevant to the safety of drugs in development and post authorization as well as knowledge of clinical research.
• Demonstrated computer experience with MS Word, Excel, Access and Outlook.
• Excellent written and verbal communication skills, organizational skills and attention to detail
• Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.
• Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
• Highly analytical with the ability to give attention to detail.
• Excellent organizational skills and capable of working efficiently.
• Capable of troubleshooting and managing multiple projects simultaneously.

Other Requirements

Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.

Competencies

• Proficient in managing safety systems, processes, and tools to ensure compliance and efficiency.
• Strong interpersonal and organizational skills, with the ability to prioritize independently and manage multiple projects simultaneously.
• Detail-oriented and self-motivated, with a focus on continuous improvement and adoption of best practices.
• Ability to lead and influence others, work effectively in a team environment and adhere to written policies and procedures.
• Proven ability to collaborate with global teams, cross-functional partners, and regulatory authorities.
• Excellent communication and presentation skills.

Additional Information

The base salary range for this full-time position is $130,000 - $150,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.