Senior Specialist, Drug Safety

Job Description

Currently, we are looking for Senior Specialist, Drug Safety. Develop and maintain the necessary processes to ensure high-quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations. Maintain knowledge of PV regulations related to drugs, vaccines, biologics and devices. Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.

What will you do?

• Lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual adverse experience case and periodic reports.
• Provide expert guidance and perform safety system configuration update and maintenance activities to ensure compliant case data handling as part of the end-to-end Individual Case Safety Report (ICSR) lifecycle: Study Configuration, Product Configuration, Reporting Destinations, Reportability Rules and Label Validation Files.
• Support Safety System Development Lifecycle (SDLC) activities to ensure these systems remain compliant with both internal and external requirements and pursue process efficiencies.
• Provide content for the ongoing development and expert review of the Global Safety Database User Manual, Standard Operating Procedures, and training material as needed to ensure accuracy.
• Provide expert guidance on the PV activities outlined by procedures (SOPs, User Manual, etc.).
• Responsible for drafting, negotiation, and maintenance of PV agreements and safety management plans.
• Identify and prioritize PV agreements and safety management plans to maintain compliance with worldwide regulatory requirements.
• Responsible for the end-to-end GCS&PV implementation and maintenance for select business deals.
• Support due diligence and qualification activities for selecting partner deals/projects.
• Interact closely with the business system owner for the maintenance of the Business Development Lifecycle Management system.
• Perform quality review of expedited and periodic reports to ensure adherence to global case processing standards and regulatory requirements.
• Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.
• Lead efforts to improve departmental efficiencies and continuous improvement.
• Process incoming communications from internal and external sources and initiate appropriate course of action and/or response.
• Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.
• Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.
• Follow company always polices and legal guidelines.
• Develop and support processes that facilitate achievement of GCS&PV objectives.
• Support any other project or perform any other task deemed appropriate by management.

Additional location(s) Compensation Information

Required Skills: Adverse Event Report, Auditing, Compliance Monitoring, Data Analysis, Drug Safety Surveillance, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Quality Compliance, Quality Control Management, Quality Reporting, Regulatory Audits, Regulatory Compliance, Regulatory Inspections, Regulatory Reporting, Regulatory Requirements, Regulatory Reviews, Risk Management, Safety Management

Employee Status: Regular

Relocation: Domestic/International

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

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