Job Description

About This Role 

The Sr Associate II, Drug Safety, PV Regulatory Intelligence and International Partner Markets (IPM) will be a supporting member within the Reporting & Submissions team in Global Case Management (GCM)/International Pharmacovigilance (IPV) group with focus on PV regulatory intelligence activities, facilitating the ongoing management of the Pharmacovigilance (PV) operations for Biogen Partners IPM. The Associate will support the Reporting & Submissions team conducting routine activities such as monitoring of submissions, generating / reviewing metrics, inspection / audit readiness, assisting with quality reviews and other tasks, as assigned. The Associate will support objectives and goals laid out by Global Case Management (GCM)/International Pharmacovigilance (IPV) group Leadership.

What You’ll Do

• Manage PV Reg Intel Mailbox, reviewing documents received from multiple sources (Service providers, Affiliates, Business Partners, Biogen stakeholders etc).
• Responsible for timely triage and communicating relevant regulatory intelligence to SMEs.
• Maintain regulatory intelligence tracker to keep a running log of the progress of any actionable intelligence from identification to item closure.
• Provide quarterly updates and escalate to management on long pending items and non-responsive SMEs
• Contributes to oversight of Biogen Partners, Distributors, Vendors, including metrics, and review of IPM trackers.
• Monitors any technical or access related issues faced by IPM users reviewing tracker periodically and ensuring resolution in timely manner.
• Supports the Organised Data Collection Programs (ODCPs) process for AE collection to ensure consistency with regulations and with departmental goals and objectives.
• Supports the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network.
• Delivers training, as required, to the Distributor Network employees using a variety of instructional techniques and modalities.
• Monitors on-time training completion and follow-up with Distributor Network employees, as applicable.
• Conducts Distributor Network quarterly meetings and follow-up/closure of pending items.
• Perform monitoring of post-marketing expedited submissions via the global safety database (GSD)
• Review Line listing and Reconciliation reports related to ICSR submission to corporate partners 
• Reviews tracker for periodic line listing and reconciliation reports sent to partners based on Safety Data Exchange Agreement (SDEA) requirements
• Supports GCM/IPM leadership in the development and ongoing management of technology solutions used to compliment the oversight of routine PV activities conducted across the Distributor network.
• Contributes to the mechanisms needed to oversee appropriate training of case intake procedures and systems to ensure adequate AE collection in the Distributor Network.
• Assists with the controlled document management lifecycle, providing input and monitoring of activities governed by Standard Operating Procedures (SOPs), Job Aids, Distribution Agreements (DAs), Regulatory Services and PV Agreements (RSPVAs), R&D Business Processes, Work Instructions, and reporting forms.
• Supports audit and inspections including follow-up of open action items and investigations as related to functional area.
• Performs administrative tasks such as:
  • attend routine PV meetings for training purposes and ensuring compliance with all assigned trainings.
  • produce regular and ad hoc reports to ensure compliance to KPIs.
  • investigate and address compliance issues.
  • perform ongoing day to day tasks including coordination of training services, reconciliation activities, maintenance of meeting minutes and trackers.
  • support ad hoc projects/activities assigned to meet evolving business needs.
  • completion of assigned trainings in timely manner.
  • adhere to local policies related to flexible working.

Who You Are

You have a solid experience in Drug Safety/Pharmacovigilance and as a person you are proactive, problem-solving, and thrives in a complex, regulated environment. You  possess strong communication skills, with the ability to manage cross-functional.  

Qualifications

• Minimum of bachelor’s level degree in a Science or Healthcare related area.
• Solid experience in Drug Safety/Pharmacovigilance.
• Highly motivated and a self-starter.
• Ability to work effectively both independently and as part of a team.
• Good written and verbal communication skills.
• Good technical writing skills with the ability to produce clear, concise documentation and communications.
• Good presentation and analytical skills.
• Strong Information Technology (IT skills); familiar with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
• Good understanding of PV activities and processes.
• Understanding of global regulatory and pharmacovigilance terms and activities.
• Ability to read and interpret global regulations/documents as received from various sources.
• Ability to identify, analyse, and summarize requirements/legislations related to pharmacovigilance.
• Knowledge of common safety database systems.
• Fluency in English (written and verbal) is required.
• Experience in Drug safety/Pharmacovigilance is required.
• Experience of working with electronic learning management systems is preferred.
• Knowledge of good GVP practices is preferred.
• Flexibility to support multiple time-zones is preferred.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.