About The Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.
Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.
Overview Of Job Role
iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:
The Pharmacovigilance (PV) Manager will be responsible and accountable for all assigned Clinical Safety and Post marketing PV activities on company clinical trials and post-marketing programs. The Pharmacovigilance Manager will be part of the newly developed, lean and efficient Benefit Risk management team, reporting to the Benefit risk management Director. The focus of this role will be on Signal and Benefit Risk, Risk management, Periodic reporting and Regulatory intelligence activities in both clinical trials and post-marketing surveillance. The PV manager will also work on development of the team's processes, be involved in PV systems development and lifecycle management, own assigned deliverablesand ensure regulatory compliance.
Scope and responsibility
- Manage and oversee Signal management, Benefit-Risk monitoring, Safety aggregate reports (e.g. PADER/PSUR/DSUR) and Regulatory Intelligence (Legislation monitoring and Product Safety Profile monitoring) in assigned clinical trials and post-marketing programs
- Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.) to execute the assigned activities (SME)
- Create, maintain and optimize Global Pharmacovigilance processes and ensure compliance withinternational law and regulations (e.g. FDA, EMA, ICH).
- Work cross-functionally with other PV department teams and other teams (e.g. Medical affairs) to gather inputs for assigned deliverables (e.g.,DSURs, PSUR, PADER, Signal management, Risk management), ensure on-time delivery and submission compliance.
- Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, IT, CPD, etc.) and externally with PV service providers and Business partners
- Deliver trainings on pharmacovigilance processes and standards to company staff and external parties
- Involved in Audits and Inspections related to Benefit Risk Management activities
Job Requirements
- Education:Master's Degree in pharmaceutical sciences or related fields medicine, pharmacy, life sciences
- Experience:7+ years inPharmacovigilance/Drug Safety in similar function with demonstrable hands on experience
- Expertise in clinical trial and post-marketing pharmacovigilance activities
- Expertise in Safety systems (e.g.,Argus, ARISg); previous experience with Veeva Platform (e.g. Safety Vault/Safety Docs) is great advantage
- Proven track record withglobal Product and Study portfolios
- Previous experience with biologic and combination products is an advantage
- Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)
- Mature self-organizational, time-management and interpersonal skills
- Excellent communication skills, maintains a positive, result oriented work environment
- Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.
- Willingness to travel internationally, as required
