JOB TITLE:   Senior PV Specialist                                          

DEPARTMENT: Pharmacovigilance         

REPORTS TO: Bunmi Urakpo                                                

FLSA STATUS: Exempt

VERSION DATE: 02June2025       

JOB SUMMARY: 

The PV Specialist - Compliance and Alliance Manager is responsible for ensuring that global pharmacovigilance activities are compliant with applicable regulations, internal procedures, and partner/vendor agreements. This role serves as a liaison between internal PV teams and external partners to manage compliance metrics, audit readiness, deviation tracking, and the oversight of safety-related agreements and alliances. This position is also responsible for the case processing workflow (triage and case Quality control (QC) for clinical trial and post-marketed events, SAE reconciliation, and safety data review. Collaborates cross-functionally with clinical, regulatory, and quality teams to ensure timely and accurate safety reporting to health authorities and business partners. Demonstrates strong knowledge of global PV regulations (ICH, FDA, EMA, MHRA) and GVP modules.

PRINCIPAL DUTIES: 

Compliance: 

·       Monitor PV compliance metrics (e.g., case processing timelines, regulatory reporting, follow-up timeliness).

·       Perform compliance investigations, root cause analyses, and propose corrective/preventive actions (CAPAs).

·       Lead or support inspection and audit preparation, execution, and follow-up activities.

• Ensure deviations are documented, tracked, and resolved in accordance with company SOPs.
• Coordinate compliance reviews of ICSR reporting (e.g., late case analysis, missed submissions).
• Act as the primary PV point of contact for alliance and vendor partner compliance matters.
• Support the development, negotiation, and maintenance of Safety Data Exchange Agreements (SDEAs).
• Monitor partner performance through KPIs and compliance dashboards; initiate remediation as needed.
• Organize and lead governance meetings with partners and licensors/licensees.
• Track partner responsibilities for safety submissions, reconciliation, and periodic safety reports.
• Maintain up-to-date documentation for compliance-related activities (e.g., metrics reports, CAPA logs).
• Review and support updates to PV SOPs, work instructions, and guidance documents as applicable.
• Collaborate cross-functionally to ensure inspection readiness across PV systems and processes.
• Assist in PV compliance training for internal and external stakeholders.
• Identify and implement process improvements based on audit findings, compliance trends, and lessons learned.

Case processing:

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing notifications as required for case management.
• Support coding review of medical history, adverse events, and concomitant medications.
• Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
• Peer reviews of cases for quality, consistency, and accuracy as needed.
• Highlight areas of concern/discrepancies to the PV team when related to ICSRs.
• Maintain regulatory and department compliance by ensuring timely completion of reports and assisting in submissions of reportable cases to regulatory agencies (if needed), study investigators, and licensing partners.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Support and contribute to the development of training materials and training delivery.
• Participate in training internal and external audiences on drug safety-related topics, as assigned.
• Evaluate project or case workflow and offer solutions for process improvement.
• Represent the PV Department in cross-functional team meetings, as needed.
• Guide departmental policies and procedures by maintaining a high level of understanding of federal and international regulations.
• Draw upon the knowledge of Drug Safety regulations & practices, disease-specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention.
• Other duties as assigned.

REQUIRED QUALIFICATIONS/EXPERIENCE:

• Strong verbal, written and interpersonal communication skills.
• High level of accuracy and attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Able to work independently and collaboratively in a multi-disciplinary team.
• Excellent organization and prioritization skills; able to multitask.
• Knowledge of global regulatory requirements (e.g., FDA, EMA, ICH, MedDRA, WHO-UMC).
• Hands-on experience with safety databases (e.g., Argus, ARISg), EDC, Veeva Vault, and other systems.
• Prior experience managing SDEAs and alliance governance preferred.
• 3–6 years of pharmacovigilance experience, including compliance or alliance/vendor oversight.
• Required: a bachelor’s degree in life sciences, pharmacy, nursing, or a related field.
• Preferred: advanced degree, RN, RPh, PharmD or equivalent.

This job description is intended to describe the general nature and level of the work being performed by employees in the position.  It is not intended to be a complete list of all responsibilities, duties, and skills for the position.  The Company reserves the right at all times, in its sole discretion, to add or subtract duties and responsibilities, as it deems necessary.