Strategic Commercial Manager leading business growth through client acquisition and team development. Responsible for achieving commercial targets and ensuring market presence.
About the role
- Product Safety & Pharmacovigilance Manager overseeing drug safety and compliance in clinical trials. Managing CROs and ensuring adherence to regulatory requirements while leading a team in Florham Park, NJ.
Responsibilities
- Manage activities of CROs, vendors, and temporary staff performing PV operations.
- Oversee and guide case processing activities to ensure effective monitoring and evaluation of product safety information.
- 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 ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids.
- Ensure PV operation continuity including maintenance of process or disaster recovery plan of Safety Database.
- Supervise and manage preparation and submission of aggregate reporting in accordance with applicable regulations.
- Maintain training matrix in PSPV team and lead trainings of PSPV members or new hires.
- Oversee preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
- Manage pharmacovigilance agreements or safety clause in contracts with partners or CROs.
- Act as the responsible contact person for safety-related aspects and PV.
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 timelines desired.
- 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.
- 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.
- Capable of troubleshooting and managing multiple projects simultaneously.
Benefits
- Health insurance
- Paid time off
- Professional development opportunities
- Flexible working arrangements
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