Lead PV Operations

Job Description

About This Role:

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a Lead Pharmacovigilance Operations. This role is open to remote candidates. As a crucial member of the Safety team, the Senior PV Operations Manager a will be responsible for supporting the PV operations of clinical development programs and accountable for managing and overseeing PV vendors. You will actively participate as a member of the Study Teams and be responsible for PV operation activities from study start-up to close-out including but not limited to: review safety management plan,  review safety reporting language in protocols, review study specific safety database configuration, manage PV record management, support database lock by liaising with PV vendors and cross-functional stakeholders.  Additionally, they will regularly engage with multiple PV vendors in different roles and capabilities to ensure the operational model meets defined strategic key performance indicators (KPIs). Your contributions will not only support our commitment to patient safety but will also influence the strategic direction of our product lifecycle.

What You’ll Do:

• Responsible safety operational content and processes for clinical trials such as protocols, CRFs, safety management plans, SAE forms, pregnancy forms; tools and processes for safety database requirements and configurations to enable safety-related activities during studies; training requirements and materials for clinical trial safety report collection
• Review and archive PV related records in various documentation management systems (e.g. TMF)
• Support clinical trial safety report collection and collaborate with other functions (e.g., Clinical Operations, Data Management, Regulatory, Biostatistics, and others) to ensure consistency with regulations and study objectives
• Oversee vendor performance and execute and monitor compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans
• Act as subject matter expert in audits / inspections, including leading Readiness for PV vendors
• Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them
• Develop, maintain and implement PV related procedural documents (e.g. SOPs)
• Contribute to business alliance management
• Establish business continuity plan for PV operation

Who You Are:

You are deeply invested in ensuring the utmost safety for patients involved in trials or using our treatments. With the ability to distill complex data into clear, actionable insights, you shine in a collaborative team setting. Your exceptional organization and time-management skills enable you to thrive in a fast-paced environment where your contributions make a significant impact on public health.

Qualifications

Required Skills:

• Bachelor’s degree in a biological or natural science, or health care discipline (e.g. nursing, pharmacy). Advanced Degree (Ph.D., MPH, NP, PharmD, etc.) preferred
• 5+ years of pharmacovigilance and GCP experience required
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Knowledge on case processing and handling of ICSRs including submissions
• Proficient in vendor oversight including KPI monitoring
• Strong organizational skills, including the ability to handle complex tasks, prioritize effectively, and project management initiatives/process improvements
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
• Demonstrated ability to work proactively and independently with minimal oversight needed by management

Additional Information

The base compensation range for this role is $124,000 - $200,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.