Associate Director Drug Safety & PV Operations

Associate Director Drug Safety & PV Operations

Requirements

• Bachelor’s degree in life sciences or related field
• Targeting 8 years of progressive experience in the pharmaceutical or biotech industry, with the majority in Pharmacovigilance
• Knowledge of relevant FDA, EU, ICH guidelines, initiatives, and regulations governing Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology, and knowledge of Clinical Trial guidelines (GCP) and regulations)

Responsibilities

• Participates in setting the direction of PV operational activities to ensure a cost-effective and scalable PV system is in place.
• Provides oversight of safety information processing, reconciliation, and reporting by outsourced vendors, including the review of Individual Case Safety Reports (ICSR) and case processing metrics.
• Management of aggregate reports, including the Development Safety Update Report (DSUR).
• Participates in the development and management of the Pharmacovigilance System Master File (PSMF).
• Liaises with DSP Quality Standards and Training (QST) in reviewing Key Performance Indicators (KPIs), including case quality, reporting, and workflow metrics to assess vendor performance, and takes appropriate action.
• Liaises cross-functionally to ensure needed PV requirements are in the contracts of other vendors receiving safety information (e.g., Commercial) and ensures appropriate procedures and processes are in place for the receipt and reconciliation of such information.
• Monitors global regulatory intelligence to ensure DSP requirements with safety reporting
• Liaises with global teams to execute deliverables, such as study deliverables, aggregate reporting, and post-marketing activities.
• Acts as safety lead for various ACADIA studies to ensure all PV activities are complete and compliant.
• In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited and aggregate safety reports to Regulatory Authorities.
• Develops, reviews, and updates drug safety forms and templates, harmonizing them with relevant clinical operation forms and templates (e.g., SAE data collection form, PADER template, etc.).
• If required, participate in the management of safety data exchange agreements with business partners.
• Participate in strategic planning, workflow development, audits, and regulatory inspections.
• Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives, AOSE templates, and other safety-related documentation as needed
• Ensures training of appropriate cross-functional personnel and external groups in drug safety principles and practices.
• Identifies and develops process improvement strategies and communicates project status updates.
• Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
• Other duties as assigned.

Preferred Qualifications

• Knowledge of Individual Case Safety Reports (ICSR) management processes, including case receipt, processing, medical review, and regulatory submission.
• Extensive knowledge of DSUR.
• Strong knowledge of MedDRA and common safety databases (ARGUS or ARISg).
• Demonstrated technical, administrative, and project management capabilities.
• Strong interpersonal, organizational, and workload planning skills and excellent verbal and written communication skills.
• Adaptable to changing priorities.
• Proven ability to manage through vision setting and constructive feedback.
• Proficient computer skills, including Microsoft Word and Excel.
• Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the department or segments of the organization.
• Adept at creating and communicating a clear vision among team members, effectively aligning resources to achieve functional area goals.