Associate Director, PV Systems Reporting & Analytics

Job Title: Associate Director, PV Systems Reporting & Analytics

Location: MA (Remote) Duration: 18 Months Travel: Occasional travel to global company sites may be required

Objective:

Oversee and support tools used for reporting and interactive analysis of data from the global pharmacovigilance (PV) database.

Provide technical and strategic input into the roadmap, planning, and implementation of PV reporting and analytics projects.

Collaborate with global PV teams, IT, QA, and vendors to ensure systems meet user needs and regulatory requirements.

Contribute to vendor oversight for outsourced PV reporting activities.

Key Responsibilities:

Lead the delivery of PV reporting and analytics system projects in collaboration with IT.

Oversee the selection, implementation, and optimization of new tools for self-service PV data reporting and analysis.

Drive continuous improvements, including automation, integration of external data sources, and implementation of industry-standard dashboards.

Serve as SME to develop roadmaps and plans for end-to-end Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.).

Develop and maintain SOPs and training programs related to PV reporting and analytics systems.

Collaborate with stakeholders (business, IT, QA) to proactively identify and address PV system requirements.

Mentor and train PV Systems team members and users to strengthen organizational expertise.

Support audits and inspections related to global PV reporting and analytics functions.

Develop, track, and report quality metrics related to global PV reports.

Education & Experience Requirements:

Bachelor’s degree required; Advanced degree preferred.

Extensive experience with Pharmacovigilance/Drug Safety Systems and BI tools (e.g., Argus, Insight, Cognos, Spotfire, SSRS).

Strong expertise in database programming (Oracle SQL, PL/SQL, Windows/Unix shell scripting).

Solid understanding of Software Development Life Cycle (SDLC) and Computer Systems Validation (21 CFR Part 11, GxP compliance).

Familiarity with MedDRA and global pharmacovigilance regulations.

Key Skills & Competencies:

Strong analytical, organizational, and time management skills.

Excellent verbal and written communication abilities.

Ability to collaborate across global, cross-functional teams.

Process-oriented with a focus on efficiency and compliance.

Experience overseeing outsourced PV reporting activities.