Pharmacovigilance associate, Safety data management
Description
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.
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:
Overview of Job Role
T he Pharmacovigilance (PV) Associate will be responsible for all assigned Clinical Safety and post-marketing PV activities . The PV Associate will be part of the ne wly developed, lean and efficient , Global Safety Data Management team , reporting to the Safety Data Management Director . The focus of this role will be on Safety data mana gement activities for company Clinical trial s as well as post-marketing programs . The PV Associate will also be involved in development of the team’s processes, and development and lifecycle management of PV systems . The PV Associate will work on assigned tasks and activities and ensur ing regulatory compliance and compliance with company processes.
Scope and responsibility
-
Work on assigned Clinical Safety and post-marketing PV tasks ( e.g. ICSR/SAE management , R egulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
-
Involved in Safety systems setup and lifecycle management ( e.g. configuration, validation, system lifecycle management, etc.)
-
Involved in maintain ing and optimiz ing Global Pharmacovigilance processes and ensur ing compliance with international law and regulations ( e.g. FDA, EMA, ICH).
-
Work cross-functionally with other PV department teams and other teams ( e.g. B enefit-Risk management, Clinical trials and Partner Compliance) , provide inputs and ensure on-time deliver y and 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 Safety Data Management activities
Job requirements
-
Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences
-
Experience: 2 + years in Pharmacovigilance/Drug Safety working in Safety data management functions with demonstrable hands on experience in c linical trial safety and post-marketing PV activities
-
Expertise working in Safety systems (e.g., Argus, ARISg ); previous experience with Veeva Safety Vault is great advantage
-
Proven track record working with global Product s and Clinical trials
-
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