Senior Manager, Drug Safety

Job Description

About This Role

The Sr. Manager, Drug Safety is responsible for establishing governance and defining standards for interactions with third party business partners in pharmacovigilance and for coordinating PV provisions for the biosimilars as mandated by the Biogen agreements with Samsung Bioepis (SB). This involves overseeing a global network of local safety responsibilities, most notably the Pharmacovigilance agreement between SB and Biogen France. The Sr. Manager is responsible for monitoring the safety of products marketed in France or used in Early Access Programs (EAP) to guarantee patients’ safety and the application of regulations. Additionally, the Sr. Manager will be accountable for medical information.

What You'll Do

In accordance with applicable guidelines (including GVPs and Bonnes pratiques de Pharmacovigilance – ANSM – in force) in Europe and in France:

Pharmacovigilance:

• Assumes oversight and governance of PV responsibilities for the SB biosimilars as per the PVA with SB partnership in pharmacovigilance.
• Maintains strong working connections with the Biogen France Responsible Pharmacist (the CPO), Biogen France PV Responsible Person (RPV), Biogen EU QPPV and Samsung (Biosimilars) EU QPPV. Ensures oversight of safety and medical information activities related to biosimilar products marketed in France.
• Contributes to PV audits and inspections
• Oversees, develops, improves and implements processes for Samsung biosimilar related regional pharmacovigilance globally including management of local/regional Pharmacovigilance agreements (PVA).
• Oversees PV and Medical Information related SB biosimilar related metrics.
• Coordinates with PVA counterparts for Samsung Biosimilars PVAs.
• Coordinates local PV controlled document management lifecycle, including authoring, updating and monitoring of Standard Operating Procedures (SOPs), Job Aids, R&D Business Processes, Work Instructions and reporting forms. For those related to Samsung biosimilars owned by SB, review for alignment with Biogen expectations including parameters within the effective (PVAs).
• Leads the PV Governance process as is applicable to Organized Data Collection Programs (ODCPs) to ensure consistency with regulations and with departmental goals and objectives. This includes oversight of the design, planning and execution of PV aspects of Biogen initiated ODCPs for Samsung biosimilars.
• Performs off-label use analysis for company’s products.
• Handles French Health Authorities requests, and appropriate reports.
• Acts as local deputy Pharmacovigilance Responsible (RPV) in the absence of the RPV.
• Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.
• Participates in the drafting of joint operating guidelines, including PV language of commercial or non-commercial service contracts.
• Leads and/or contributes to Regional or Global strategic priorities, projects and responsibilities, as required.
• Fosters an environment of sharing best practices, learnings and innovations with the wider IPV affiliate network.
• Monitors the benefit/risk ratio of drugs
• Collects, documents, evaluates, follows-up and archives pharmacovigilance cases in compliance with procedures and regulations
• Manages data entry and quality control of PV cases
• Manages and analyze local pharmacovigilance signal detection for the company's products
• Performs off-label use analysis for company's products
• Handles French Health Authorities requests, and appropriate reports
• Manages legal cases with legal department
• Develops PV training materials for Biogen France employees and Biogen France vendors and training delivery when necessary
• Oversees the PV vendors
• Participates in the drafting of joint operating guidelines, including PV language of commercial or non-commercial service contracts
• Reviews and monitors local organized data collection programs as well as any other local programs
• Handles PML activities
• Supervises junior associates and trainees
• Acts as local deputy Pharmacovigilance Responsible (RPV) in the absence of the RPV
• Acts as Safety expert for PV activities and product
• Collaborates with the International Pharmacovigilance (SABR)

Medical Information:

• Requests handling and processing from healthcare professionals and patients on the characteristics and use of the company’s products.
• Initiation and participation in the validation circuit of standard letters.
• Oversight of medical information vendors.

Quality Assurance:

• Writing of procedures and job aids related to the department’s activities.
• Treatment of non-conformities in relation to the quality management system (pharmacovigilance procedures) detected by the department or during audits/inspections and in connection with pharmacovigilance and medical information activities.
• Monitoring of PV and Medical Information KPIs.
• Organization of reconciliation and quality control activities.

Qualifications

Required Skills

• At least 7 years in drug safety/PV in pharmaceutical industry setting
• Experience with interacting with third parties (e.g. PV operations vendors) required
• Knowledge of Good PV Practices
• Direct experience in GxP compliant quality systems preferred
• Knowledge of Adverse Events Intake systems
• Experience in writing procedures, training materials and effectively delivering training to a diverse audience
• Strong knowledge of Global and Regional and PV regulations and requirements, especially for Biosimilars
• Experience with Global organization would be a best
• Experience (e.g. interviewee, control room document request) of Audits and Regulatory Inspections preferred
• Proficiency in English (written and verbal), if not native language
• Excellent written and verbal communication skills
• Well-developed technical writing skills with the ability to produce clear, concise documentation and communications.
• Good presentation and analytical skills
• Demonstrated ability to drive and implement complex initiatives across a matrix organization
• Demonstrated ability to envision and influence operational strategies
• Ability to work collaboratively with others from any functional area or background to influence thinking and gain acceptance
• Self-awareness of communication style and cultural differences
• Consultive style: Ability to formulate and articulate a perspective and present it in a manner that generates understanding and alignment
• Self-motivated and capable of operating independently with limited oversight. Strong sense of personal accountability for work tasks
• Comfortable acting in a role as individual contributor and influencer
• Good proficiency with common software such as Microsoft Word, Excel, PowerPoint and Outlook
• Individual is a self-starter, ability to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize
• Strong decision-making skills required
• Must demonstrate initiative to effectively identify and communicate issues

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.