Sr. Director Drug Safety and Pharmacovigilance

Duties

• Supports all compliant PV system related activities, by ensuring appropriate processes are in place for the collection, collation, evaluation and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements.
• Affords assistance with implementation of drug safety standards across other areas that input to the PV system such as clinical research, medical affairs, commercial, etc.
• Contributes to the preparation and presentation of Key Performance Indicator (KPI) reports.
• Serves as a point of contact for Drug Safety & PV (DSP) Training administration and management.
• Maintains all required SOP training matrices for all DSP roles.
• Supports PV inspections and audits; collaborates cross-functionally in preparation of responses to findings.
• Leads monitoring and management of DSP quality events/deviations investigations.
• Evaluates adequacy and completeness of CAPAs and Effectiveness Checks (ECs) originated from audits, and/or quality events/deviations.
• Supports Quality Management Reviews for all DSP deliverables.
• Supports DSP procedural development and maintenance; collaborating with Subject Matter Experts (SMEs); liaises with other departments on cross-functional procedures that involve DSP.
• Supports Regulatory Intelligence for DSP.
• Contributes to documents describing the PV system as required by regulations (e.g., EU PV Masterfile).
• Assists in preparation and execution of DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory).

Skills

• Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, development and maintenance of SOPs and training programs, and PV systems/databases.
• Experience with Veeva and ARGUS is preferred.
• Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, and reporting to Health Authorities worldwide.
• Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice and make sound decisions.

Requirements

• Experience in the pharmaceutical or biotech industry, including 3 years in Pharmacovigilance with prior oversight of PV compliance, quality and training.
• Experience with industry interpretation of regulatory expectations and with pharmacovigilance inspections by major global Health Authorities.
• Bachelor’s degree in Life Science or related field.