Product Safety & Pharmacovigilance Manager

Shionogi•Florham Park, NJ

57d•Hybrid

About The Position

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.

Requirements

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.
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.
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.

Responsibilities

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.