Safety and PV Ops Specialist II

This is a fully remote position, open to applicants in United States.

📋 Description

• Maintains a comprehensive repository of all pertinent documents (e.g., Training, Safety & Pharmacovigilance Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, and lists of audits/inspections).

• Develops and sustains Job Aids and process documentation, ensuring all necessary supporting documentation is maintained.

• Ensures adherence to Standard Operating Procedures (SOP), Policies, and SMP documents.

• Keeps abreast of all relevant FDA/EU/ICH guidelines and regulations pertaining to safety and PV reporting.

• Contributes to achieving annual revenue goals by collaborating with operational team members and Therapeutic BU Project Managers / Project Directors to ensure the accurate and timely recognition of the BU in RBB.

• Assists in the preparation of information for the Executive Project Reviews and the monthly Safety & Pharmacovigilance finance meeting.

• Provides metrics as required at agreed intervals based on assigned duties.

• Undertakes other work-related responsibilities as assigned.

• Aids the Quality Planning activities by offering controlled document support during development, revision, or review; assists in the creation of department or client-specific documents; tracks and communicates quality metrics to assess, evaluate, and promote team/individual performance to meet expected quality standards.

• Supports the Quality Compliance activities by verifying the performance of quality control measures.

⛳️ Requirements

• A minimum of 3 years of experience in Pharmacovigilance (PV).

• Proficient in technical writing within the PV Department.

• Exceptional written and verbal communication skills.

• Preference will be given to candidates with hands-on experience using PDFs, PowerPoint, and other office applications.

🏝️ Benefits

• We are dedicated to fostering the development of our employees through career growth and advancement; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are committed to cultivating an inclusive culture where you can genuinely be yourself.