Senior Pharmacovigilance Scientist – Global Trial Safety

Alvotech; United States; Remote; USD 90,000 - 135,000; Full time

Job summary

Alvotech is seeking aSenior Pharmacovigilance professional to manage clinical trial safety activities, including SMPs, protocols, eTMF and IB across global trials. You will ensure compliance with safety regulations and lead cross-functional collaboration with Medical Affairs, Quality and Regulatory teams.

The role requires hands-on PV experience, knowledge of safety systems such as Argus/ARISg and Veeva platforms, and the ability to travel internationally.

Qualifications

• Master’s degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences).
• 4+ years in Pharmacovigilance/Drug Safety with hands-on experience.
• Hands-on experience in clinical trial safety activities.
• Expertise in Safety systems (Argus, ARISg); experience with Veeva Platform (Safety Vault/Safety Docs) is a plus.
• Proven track record with global product and study portfolios.
• Experience with biologic and combination products is an advantage.
• Knowledge of PV processes, directives, regulations and guidelines (21 CFR, ICH, GVP, GCP, CIOMS).
• Strong self-organization, time-management and interpersonal skills.
• Excellent communication, positive, results-oriented attitude.
• Ability to work independently, plan, organize and deliver in a multicultural team.
• Willingness to travel internationally.

Responsibilities

• Manage and oversee Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB).
• Involved in Safety systems setup and lifecycle management to execute assigned activities ( SME).
• Create, maintain and optimize Global Pharmacovigilance processes and ensure compliance with international regulations (FDA, EMA, ICH).
• Work cross-functionally with PV, Medical Affairs, Quality, Regulatory, IT and external PV service providers for deliverables and on-time delivery.
• Deliver trainings on pharmacovigilance processes and standards to staff and external parties.
• Involved in Audits and Inspections related to Benefit Risk Management activities.

Skills

Pharmacovigilance

Drug Safety

Clinical trial safety

Safety systems

Veeva Platform knowledge

Education

Master’s Degree in pharmaceutical sciences or related fields

Tools

Argus

ARISg

Veeva Safety Vault/Docs

Job description

Alvotech is seeking aSenior Pharmacovigilance professional to manage clinical trial safety activities, including SMPs, protocols, eTMF and IB across global trials. You will ensure compliance with safety regulations and lead cross-functional collaboration with Medical Affairs, Quality and Regulatory teams.

The role requires hands-on PV experience, knowledge of safety systems such as Argus/ARISg and Veeva platforms, and the ability to travel internationally.