Director, Pharmacovigilance and Drug Safety (Operations & Compliance)

We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. This important leadership role in the Pharmacovigilance Operations & Compliance team will be responsible for the establishment, maintenance and oversight of appropriate procedures and systems to assure adherence to local and international regulatory requirements for collection, processing, and reporting of safety information throughout the product life cycle.  They may be deployed to one or more of the key areas of process and performance excellence focus within the Pharmacovigilance Operations & Compliance remit:  safety report case management, quality & compliance, safety agreements, safety systems, and vendor management.       

This position reports to the Executive Director, Pharmacovigilance Operations & Compliance, and will be ideally located in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. 

RESPONSIBILITIES:
Case Processing: 

• Act as operational lead for case management including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training.
• Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB).
• Provides operational leadership for case management workflow, overseeing case processing activities and ensuring critical timelines and compliance metrics are met.
• Collaborates with data management and other stakeholders as appropriate for safety data reconciliation; follows up with to facilitate prompt resolution of any discrepancies.
• Serves as SME/lead for PV compliance and inspection and audit readiness for all, workflow, KPI’s, and case management- related topics.

Safety Systems 

• Leads the GSDB implementation & maintenance activities including but not limited to validation, data migration and associated change management actions.
• Acts as system administrator for the GSDB and data visualization tools.
• Provides vendor oversight to the GSDB and data visualization application cloud hosting provider (CHP).
• Establishes roles and responsibilities between sponsor and CHP in day-to-day operations and preparation for audits and inspections.
• Collaborates with other Xenon personnel and other functions to prepare safety data and Argus reports as needed.
• Generate and distribute data listings and reports as needed.
• Manage PV mailboxes and distribution lists.
• Works closely with Xenon IT in developing processes and providing oversight for the data security and data protection of the GSDB, disaster recovery and business continuity.  
• Serves as SME/lead for PV compliance and inspection and audit readiness for all GSDB and safety systems related topics.

Compliance, Quality & Pharmacovigilance Agreements

• Monitors and ensures compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities).
• Serves as SME/lead for PV compliance, PV Agreements, and inspection and audit readiness for all compliance and quality related topics.
• Ensures monitoring, timely communication and impact assessment for regulatory intelligence in relevant health authority requirements for pharmacovigilance.
• Authors and maintains pharmacovigilance agreements, including but not limited to safety data exchange agreements, safety handling plans, safety management plans, pharmacovigilance clause in non-PV vendor or business partner contracts or agreements and memorandum.
• Maintains tracking of PV Agreements and corresponding obligations to ensure adherence and oversight. 

For All Areas of Process & Performance Excellence, the Director PV Operations & Compliance:

• Responsible for reports writing and vendor management for related activities. 
• Participates in the timely analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports (CSRs).
• Monitors activities of CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, applicable SOPs and WIs, other study plans, metrics, and contractual agreements.
• Develops and maintains SOPs, Wis, and controlled governing procedural guidance documents in collaboration with other functions, including CROs and vendors as applicable.
• Participates and leads as appropriate DSPV and cross-functional program team meetings and vendor oversight meetings where operational items are discussed and addressed regularly.
• Provides direct vendor oversight for the generation of validated safety reports and complex queries from the GSDB.
• Contributes to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, through the preparation of reports and data outputs and by ensuring prompt access to high quality data for the assessment of safety signals.
• Collaborates with safety physicians and other members of DSPV, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing safety data outputs.
• Contributes to preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports.
• Collaborates with clinical teams, medical affairs, and other stakeholders in developing data quality standards for clinical studies, organized data collection programs, literature, and spontaneous sources, as well as ongoing data review and query follow up.
• Assists the SVP of DSPV in the preparation, facilitation, and documentation of safety governance meetings.
• Prepares and provides training for DSPV team, PV and non-PV vendors, and Safety Reporting training at investigator meetings as needed.
• Serves as lead for developing the Training Curriculum for DSPV and overseeing the Training Curriculum for the PV vendors.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• Master’s degree in relevant field (Life sciences), nursing degree or pharmacy degree required; for exceptional candidates, a Bachelor of Science Degree in Life Sciences combined with relevant experience will be considered.
• A minimum of 8-10 years of experience in pharmacovigilance with a focus on operations, across development and post-marketed phases, is required.
• 3 years of experience working with and providing oversight to PV vendors and/or hosting partners.  
• 3 years of experience leading people or teams.
• Prior experience in GSDB implementation, validation, and data migration is required.
• Working experience with safety databases (preferably Argus) and data visualization/analytics reports.
• Strong knowledge of ICH, Canadian, US & International regulations, and requirements for pharmacovigilance.
• Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, PBRER).
• Business acumen (MBA preferred)
• Project management experience a plus
• Lean-sigma experience a plus

The base salary range for this role is $210,000 to $239,400 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.