Associate Director, Pharmacovigilance Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the collection, processing, reconciliation, and reporting of ICSR, along with quality assurance activities.

• Manage pharmacovigilance vendor operations, key performance indicators, governance, and readiness for inspections.

• Ensure adherence to global pharmacovigilance regulations and reporting deadlines.

• Assist in the creation of pharmacovigilance standard operating procedures, work instructions, and guidance materials.

• Design and maintain Safety Management Plans and Pharmacovigilance/Safety Data Exchange Agreements.

• Oversee the reconciliation of safety and clinical databases, as well as case exchanges with partners.

• Manage the configuration and maintenance of the safety database.

• Support pharmacovigilance audits and inspections as a subject-matter expert.

• Supervise deviations and corrective and preventive action (CAPA) initiatives.

• Collaborate with Clinical Operations, Regulatory Affairs, and other cross-functional teams on safety submissions.

• Represent Pharmacovigilance Operations in operational processes, initiatives, governance forums, and external collaborations.

• Act as the primary Pharmacovigilance Operations point of contact for Contract Research Organizations (CROs).

• Provide pharmacovigilance expertise for Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and other safety-related deliverables.

• Engage in cross-functional study data monitoring activities.

• Assist with departmental budgets, Master Service Agreements (MSAs), Statements of Work (SOWs), invoices, and vendor payments.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.

• At least 10+ years of experience in pharmacovigilance within Biotech, Pharma, or a CRO.

• Practical experience in vendor oversight, covering governance, KPI compliance, and management of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).

• Previous experience with a Safety Database such as Argus or ARISg.

• Background in Clinical and Post-Market Safety and Risk Management throughout various product life-cycle stages.

• Proven ability to thrive in a matrixed, fast-paced environment while managing multiple projects.

• Capable of creatively addressing issues and mitigating risks.

• Strong comprehension of global pharmacovigilance regulatory demands and timelines, including those from the FDA, EMA, MHRA, PMDA, and E2B R3.

• Familiarity with pharmacovigilance systems such as Argus, ArisGlobal, and Vault Safety.

• Experience collaborating with management and cross-functional stakeholders.

• Ability to work autonomously, prioritize tasks, and make decisions with minimal supervision.

• Skillful in interpreting regulatory guidance and developing compliant strategies.

• Excellent analytical and decision-making capabilities.

🏝️ Benefits

• Bonus

• Stock options

• Comprehensive benefits

• Potential for variable compensation as part of the overall compensation package