Pharmacovigilance (PV) Operations Consultant

Pharmacovigilance (PV) Operations Consultant

Location: Marlborough, MA

Duration: 03 Months contract on W2

The PV Operations Consultant is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (e.g. Commercial) and will be responsible for adverse event handling and reporting and for general PVRM operations, including support of the global PV system.

This role is responsible for training management, including development and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the CTSA mailbox, and is the PVRM Team Room administrator, including file management, archiving activities, and document retention initiatives.

Additionally, this position contributes to audit and inspection preparedness, and is a member of a cross-functional working team supporting PVRM audits and inspections.

This position works closely with the Information Management (IM) and Safety Science groups as part of a matrix team to support PV activities.

Essential Functions Required for Job:

• Work within the global PV system to ensure alignment in process / procedure with regards to case processing operations.
• Works closely with the CTSA team member responsible for PVRM and non-PVRM vendor compliance management to address compliance issues originating with the vendor.
• Conducts routine AE case quality checks and supports the IM team with ad-hoc projects such as QC of test cases for special projects or during database upgrades or migration.
• Supports PVRM vendors to the responsibilities outlined in the contract and statement of work. Supports the development of a strategic relationship with the vendor and understands the vendor's business to ensure consistent and quality vendor performance.
• This also includes liaising with other Client's departments to ensure non-PVRM vendors are meeting their AE training and reporting requirements.
• Manages a subset of scope of the vendor responsible for rest of world reporting to investigational licenses.
• Liaises with non PVRM groups responsible for organized data collection schemes to ensure the collection and reconciliation of safety information generated from these activities.
• Manages PVRM reconciliation with internal and external stakeholders.
• Works closely with PVRM colleagues / functions in business-as-usual operations to ensure consistent and efficient procedures and process in accordance with regulations and best practices.
• Manages the annual review and release of companywide Adverse Event (AE) policy training, ensuring that all training materials are compliant with corporate policies, SOPs, and local/global regulations. Manages PVRM document storage ensuring all pertinent documents are processed and filed in accordance with SOPs.
• Manages archiving activities, including interactions with archiving vendors as applicable. Serves as records Information Management coordinator.
• Participates in audit and inspection preparation as part of a cross-functional working team supporting regulatory inspections and internal audits.
• Manages other PVRM or cross-functional ad-hoc projects or assignments that require compliance, training & strategic alliance input, supporting desired high-performance "Safety First" culture in line with Client's values and reinforcing related behaviors.

Skills:

Experience in case processing group or CRO preferred but not mandatory. Understanding of U.S. regulations and a fundamental working knowledge of global regulations and guidelines, e.g., US, EEA, UK, and Canadian regulations and European & Canadian and ICH guidelines, GVP, and other applicable guidance is preferred. Highly self-motivated and able to work effectively with moderate supervision. Excellent time management and organizational skills, the ability to manage multiple competing priorities, and able to work effectively in multi-functional teams. Skilled in project management. Excellent communication skills. Proficient in MS Office applications, especially Word, Excel and PowerPoint.

Other requirements (licenses, certifications, specialized training, and physical or mental abilities required):

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters while working at Client's is considered confidential.

Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Client's are carried out with the best industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast-paced environment requires handling multiple demands. Must be able to exercise appropriate judgment, as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Education level and/or relevant experience(s): Bachelor's degree in a scientific or health-related field preferred. In the absence of a bachelor's degree, at least six (6) years of relevant experience in a clinical setting/pharmaceutical company. At least four (4) years of experience in Pharmacovigilance.

Required Skills: CLINICAL PHARMACY

Languages: English: Read, Write, Speak

Minimum Degree Required: Bachelor's Degree