Senior Grid Connection Manager managing the net connection process for battery storage projects in Germany. Collaborating with grid operators and internal teams to ensure project feasibility and compliance.
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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