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Senior Associate II, Drug Safety, PV Regulatory Intelligence Specialist
2 months ago
We are seeking a highly motivated and detail-oriented Senior Associate II, Drug Safety, PV Regulatory Intelligence to join our team. As a key member of our Reporting & Submissions team, you will play a critical role in facilitating the ongoing management of Pharmacovigilance (PV) operations for Biogen Partners International Partner Markets (IPM).
Key Responsibilities:
- Manage the PV Reg Intel Mailbox, reviewing documents received from multiple sources and communicating relevant regulatory intelligence to Subject Matter Experts (SMEs).
- Responsible for timely triage and escalation of regulatory intelligence to SMEs.
- Maintain a regulatory intelligence tracker to keep a running log of actionable intelligence from identification to item closure.
- Provide quarterly updates and escalate to management on long-pending items and non-responsive SMEs.
- Contribute to the oversight of Biogen Partners, Distributors, and Vendors, including metrics and review of IPM trackers.
- Monitor technical or access-related issues faced by IPM users and ensure timely resolution.
- Support the Organized Data Collection Programs (ODCPs) process for Adverse Event (AE) collection to ensure consistency with regulations and departmental goals.
- Support the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network.
- Deliver training to Distributor Network employees using various instructional techniques and modalities.
- Monitor on-time training completion and follow-up with Distributor Network employees as applicable.
- Conduct 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.
- Support Global Case Management/IPM leadership in the development and ongoing management of technology solutions used to complement the oversight of routine PV activities conducted across the Distributor network.
- Contribute to the mechanisms needed to oversee appropriate training of case intake procedures and systems to ensure adequate AE collection in the Distributor Network.
- Assist 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).
- Support audit and inspections, including follow-up of open action items and investigations related to the functional area.
- Perform administrative tasks, including attending routine PV meetings, producing regular and ad-hoc reports, investigating compliance issues, and performing ongoing day-to-day tasks.
You will be responsible for managing the PV Reg Intel Mailbox, reviewing documents, and communicating regulatory intelligence to SMEs. You will also maintain a regulatory intelligence tracker, provide quarterly updates, and contribute to the oversight of Biogen Partners, Distributors, and Vendors.
Who You AreWe are looking for a proactive, problem-solving individual with a solid experience in Drug Safety/Pharmacovigilance. You should possess strong communication skills, with the ability to manage cross-functional teams. You should also have a good understanding of PV activities and processes, as well as global regulatory and pharmacovigilance terms and activities.
Qualifications- Minimum of a 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, and 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, analyze, 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.
