Lead Pharmacovigilance Operations Manager
1 week ago
HI-Bio, Inc., a Biogen company, is in search of a Lead Pharmacovigilance Operations Manager.
As an integral part of the Safety team, the Lead PV Operations Manager will play a vital role in facilitating the PV operations of clinical development initiatives and will be accountable for the management and oversight of PV vendors.
Your involvement will include active participation as a member of the Study Teams, overseeing PV operational tasks from the initiation of studies to their conclusion. This encompasses, but is not limited to: evaluating safety management plans, assessing safety reporting language in protocols, reviewing study-specific safety database configurations, managing PV record maintenance, and supporting database lock processes by coordinating with PV vendors and cross-functional stakeholders.
Moreover, you will frequently interact with various PV vendors in diverse roles and capacities to ensure that the operational model aligns with established strategic key performance indicators (KPIs).
Your efforts will not only bolster our dedication to patient safety but will also shape the strategic trajectory of our product lifecycle.
Key Responsibilities:
Oversee safety operational content and processes for clinical trials, including protocols, CRFs, safety management plans, SAE forms, and pregnancy forms; develop tools and processes for safety database requirements and configurations to facilitate safety-related activities during studies; create training requirements and materials for clinical trial safety report collection.
Review and archive PV-related documentation in various management systems (e.g., TMF).
Support the collection of clinical trial safety reports and collaborate with other departments (e.g., Clinical Operations, Data Management, Regulatory, Biostatistics, and others) to ensure alignment with regulations and study objectives.
Monitor vendor performance and ensure compliance through various oversight activities and reports, implementing effective Corrective and Preventative Action plans as necessary.
Serve as a subject matter expert during audits and inspections, including leading readiness efforts for PV vendors.
Identify gaps and opportunities for enhancement within the PV system and spearhead strategic initiatives to address these areas.
Develop, maintain, and implement procedural documents related to PV (e.g., SOPs).
Contribute to the management of business alliances.
Establish a business continuity plan for PV operations.
This position offers a hybrid work model.
Who You Are:
You are deeply committed to ensuring the highest level of safety for patients participating in trials or utilizing our treatments. With a talent for translating complex data into clear, actionable insights, you excel in a collaborative team environment.
Your outstanding organizational and time-management skills empower you to thrive in a dynamic setting where your contributions significantly impact public health.
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