Senior Manager, Pharmacovigilance

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

📋 Description

• Act as a pharmacovigilance expert for both ongoing and upcoming clinical trials, including Phase 1 studies and the Phase 3 PHrontier study.

• Manage the complete case process for serious adverse events, encompassing intake, triage, coordination of medical reviews, regulatory reporting, and ICSR quality control.

• Maintain safety communication channels.

• Oversee expedited reporting timelines and monitor case quality metrics.

• Reconcile safety data across clinical operations, CROs, and safety vendors.

• Assist with event adjudication, Safety Review Committee activities, and IDMCs.

• Review and draft safety documents, such as Safety Management Plans, Investigator Brochures, protocols, informed consent forms, and Letters of Authorization.

• Support quarterly activities of the Safety Review Committee and keep signal assessment logs updated.

• Aid in signal detection, validation, evaluation, and escalation processes.

• Contribute to the creation of risk management plans and safety monitoring plans.

• Review aggregate safety reports, including DSURs, six-month line listings, and ad hoc safety summaries.

• Maintain reporting schedules and data-lock timelines.

• Monitor safety-related regulatory commitments and assist in responses to health authority inquiries.

• Supervise relationships with PV vendors and CROs, including Oracle Argus Safety, case processing, and literature surveillance.

• Manage vendor governance meetings, KPIs, quality metrics, issue escalation, and CAPA follow-up.

• Support the qualification and onboarding of PV vendors, including PVAs.

• Ensure adherence to ICH-GCP, FDA, EMA, global regulations, and GVP guidance.

• Author, review, and maintain pharmacovigilance Standard Operating Procedures (SOPs), work instructions, and controlled documents.

• Engage in audit and inspection readiness activities.

• Conduct quarterly quality control of the electronic Trial Master File.

• Represent the Pharmacovigilance team in cross-functional safety management and CRO meetings.

• Provide pharmacovigilance training and support to internal stakeholders and investigator sites.

• Mentor junior safety personnel and assist in strategic pharmacovigilance planning.

⛳️ Requirements

• A Bachelor's degree in life sciences, nursing, pharmacy, or a related field is required.

• A minimum of approximately 7+ years of experience in pharmacovigilance or drug safety within the biotechnology or pharmaceutical industry.

• Proven experience in clinical trial safety surveillance and case management.

• Practical knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH E2 series, and GVP modules.

• Experience in authoring or contributing to DSURs, PSURs/PBRERs, and risk management plans.

• Familiarity with safety database systems like Oracle Argus Safety.

• Exceptional analytical, medical/scientific writing, and cross-functional communication skills.

• Capability to independently manage multiple priorities in a fast-paced, resource-constrained biotech setting.

• Experience in post-marketing pharmacovigilance and/or launch-readiness.

• Experience supporting health authority inspections or internal/external audits.

• Experience in negotiating or managing Safety Data Exchange Agreements (SDEAs) and pharmacovigilance agreements (PVAs) with development or commercial partners.

🏝️ Benefits

• Equal employment opportunities and protection against discrimination and harassment.

• The chance to work in a dynamic, expanding biotechnology environment.

• Mentorship and guidance opportunities within the pharmacovigilance function.