Specifics of the role:
• Manage and oversee Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB, etc.) for Alvotech Clinical trials

• 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 with international 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 clinical trial deliverables (e.g. SMP, Protocol, eTMF, IB, etc.) and ensure on-time delivery 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 Benefit Risk Management activities

Minimum education and experience required for the role:
• Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences

• Experience: 4+ years in Pharmacovigilance/Drug Safety in similar functions with demonstrable hands on experience

• Hands-on experience in clinical trial safety activities

• Expertise in Safety systems (e.g., Argus, ARISg); previous experience with Veeva Platform (e.g. Safety Vault/Safety Docs) is outstanding advantage

• Proven track record with global 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, resul

📌 Senior Scientist, Pharmacovigilance (India)
🏢 Alvotech
📍 India