Senior Director, Pharmacovigilance Operations
DBV Technologies
5 hours ago
Remote friendly (Warren, NJ)
United States
Operations
Key Responsibilities:
- Lead and oversee PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
- Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs, MDRs) and lead aggregate safety reporting (e.g., DSURs, PSURs/PBRERs).
- Manage PV vendor relationships (case processing and safety database vendors); establish and monitor KPIs, quality metrics, and service performance.
- Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.
- Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, Health Canada, EMA, ICH, and global PV regulations.
- Serve as the primary PV Operations interface with Medical Affairs, Clinical Development, Regulatory Affairs, Quality, and external partners.
- Lead and/or contribute to safety governance activities and committees.
- Drive inspection and audit readiness, including supporting health authority inspections.
- Contribute to health authority inquiry responses and interactions.
- Mentor and develop PV Operations staff and help scale the pharmacovigilance function.
Qualifications:
- Bachelor’s degree in Pharmacy, Nursing, or a related healthcare field required; MS/PharmD/PhD preferred.
- Minimum 12 years of pharmacovigilance experience in the biopharmaceutical industry.
- At least 5 years of leadership/management experience overseeing PV operations and/or vendors.
- Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, Health Canada, EMA, ICH).
- Proficiency with safety databases (e.g., Argus, ArisG), case processing workflows, and regulatory safety reporting.
- Experience building or scaling PV operational processes in a growing organization.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Ability to operate independently and strategically in a small, evolving organization.
- Prior experience in immunology, pediatrics, or related therapeutic areas.
- Experience supporting clinical development programs in a biotech setting.
- Lead and oversee PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
- Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs, MDRs) and lead aggregate safety reporting (e.g., DSURs, PSURs/PBRERs).
- Manage PV vendor relationships (case processing and safety database vendors); establish and monitor KPIs, quality metrics, and service performance.
- Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.
- Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, Health Canada, EMA, ICH, and global PV regulations.
- Serve as the primary PV Operations interface with Medical Affairs, Clinical Development, Regulatory Affairs, Quality, and external partners.
- Lead and/or contribute to safety governance activities and committees.
- Drive inspection and audit readiness, including supporting health authority inspections.
- Contribute to health authority inquiry responses and interactions.
- Mentor and develop PV Operations staff and help scale the pharmacovigilance function.
Qualifications:
- Bachelor’s degree in Pharmacy, Nursing, or a related healthcare field required; MS/PharmD/PhD preferred.
- Minimum 12 years of pharmacovigilance experience in the biopharmaceutical industry.
- At least 5 years of leadership/management experience overseeing PV operations and/or vendors.
- Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, Health Canada, EMA, ICH).
- Proficiency with safety databases (e.g., Argus, ArisG), case processing workflows, and regulatory safety reporting.
- Experience building or scaling PV operational processes in a growing organization.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Ability to operate independently and strategically in a small, evolving organization.
- Prior experience in immunology, pediatrics, or related therapeutic areas.
- Experience supporting clinical development programs in a biotech setting.