Associate Director/Director, Drug Safety and Pharmacovigilance Operations and Systems

Role Summary

Associate Director/Director, Drug Safety and Pharmacovigilance Operations and Systems. Based in Needham, MA (Boston area hybrid). Lead for maintenance and oversight of procedures and systems to ensure regulatory compliance for collection, processing, and reporting of safety information across the product life cycle. May be deployed to multiple areas within Pharmacovigilance Operations, including safety report case management, quality & compliance, safety agreements, safety systems, and vendor management.

Responsibilities

• Act as a DSPV Operations study lead for case management including vendor oversight, forecasting, budgeting, compliance, KPIs, and training.
• Provide operational leadership for case management workflow, ensuring timely and compliant case processing.
• Collaborate with data management and stakeholders for safety data reconciliation and discrepancy resolution.
• Serve as SME for DSPV compliance and inspection/audit readiness for case management topics.
• Collaborate to prepare safety data listings and reports as needed.
• Assist with safety database maintenance including validation, data migration, and change management.
• Manage PV mailboxes and distribution lists.
• Monitor and ensure compliance with global regulations and safety reporting timelines, generating compliance reports for DSPV activities.
• Serve as SME for PV compliance, PV Agreements, and inspection/audit readiness for compliance and quality topics.
• Author and maintain pharmacovigilance agreements (e.g., safety data exchange, safety handling plans, safety management plans).
• Monitor CROs/partners to ensure adherence to study protocols, Safety Management Plans, SOPs/WIs, and contracts.
• Develop and maintain SOPs/WIs and procedural guidance with other functions.
• Lead DSPV and cross-functional program team and vendor oversight meetings as appropriate.
• Provide vendor oversight for generating validated safety reports from the safety database.
• Collaborate with safety physicians, DSPV, CDM, biostatistics, and vendors to develop safety data review strategy and outputs.
• Assist in preparing responses to health authority queries and producing aggregate safety reports.
• Provide training for DSPV team, PV/non-PV vendors, and Investigator meeting safety reporting training as applicable.
• Adhere to company policies and ensure understanding by direct reports, if any.
• Other duties as assigned. Some international travel may be required.

Qualifications

• Health Care Professional degree preferred (e.g., RN/BSN/MSN, NP, PharmD). A Bachelor of Science in Life Sciences with relevant experience may be considered.
• Associate Director: minimum bachelor‚Äôs degree with 8+ years of management experience in drug safety & pharmacovigilance operations in clinical trials and/or post-marketing environments.
• Director: minimum bachelor‚Äôs degree with 10+ years of management experience in drug safety & pharmacovigilance operations in clinical trials and/or post-marketing environments; master‚Äôs degree preferred.
• Five years of experience with oversight of PV vendors/hosting partners.
• Experience preparing/reviewing outputs for DSUR, PBRER, etc.
• Experience with FDA/EMA regulations and ICH guidance for pharmacovigilance.
• Knowledge of drug development, pharmacovigilance databases, and MedDRA coding.
• Understanding of clinical disease states and treatment implications.
• Data handling, visualization, statistics, and technical writing skills.
• Experience with safety databases (preferably Argus) and data visualization/analytics applications.
• Strategic thinking with focus on data integrity and high-quality outputs.
• Excellent verbal/written communication and presentation skills.
• Strong time management and ability to prioritize to meet deadlines.
• Ability to work independently and in a collaborative matrix environment.