Alvotech is hiring a Senior Scientist, Pharmacovigilance for a full-time, fully remote position based in the India Home Office. The role focuses on clinical trial safety, pharmacovigilance systems, global PV processes, regulatory compliance, cross-functional collaboration, training, and Benefit Risk Management activities.
Job Details
| Job Detail | Information |
|---|---|
| Company | Alvotech |
| Position | Senior Scientist, Pharmacovigilance |
| Location | India Home Office |
| Work Model | Fully Remote |
| Job Type | Full Time |
| Job Requisition ID | JR100566 |
| Application Deadline | October 13, 2026 |
Position: Senior Scientist, Pharmacovigilance
The Senior Scientist will independently manage assigned pharmacovigilance activities, with a focus on clinical trial safety, safety systems, global PV processes, regulatory compliance, and collaboration with internal and external stakeholders.
Responsibilities
- Manage and oversee clinical trial safety activities and preparation and management of related documents, including SMP, Protocol, eTMF, and IB.
- Support safety systems setup and lifecycle management, including configuration and validation.
- Create, maintain, and optimize global Pharmacovigilance processes.
- Ensure compliance with international laws and regulations, including FDA, EMA, and ICH requirements.
- Collaborate with PV, Medical Affairs, Quality, Regulatory, IT, CPD, and other teams on clinical trial deliverables.
- Work with external PV service providers and business partners.
- Deliver training on pharmacovigilance processes and standards to company staff and external parties.
- Participate in audits and inspections related to Benefit Risk Management activities.
Eligibility & Qualifications
- Master’s Degree in pharmaceutical sciences or related fields such as Medicine, Pharmacy, or Life Sciences.
- 4+ years of experience in Pharmacovigilance/Drug Safety in similar functions, with demonstrable hands-on experience.
- Hands-on experience in clinical trial safety activities.
- Expertise in safety systems such as Argus and ARISg.
- Previous experience with the Veeva Platform, including Safety Vault/Safety Docs, is an advantage.
- Proven experience 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 including 21 CFR, ICH, GVP, GCP, and CIOMS.
- Willingness to travel internationally as required.
Required Skills
- Pharmacovigilance and Drug Safety
- Clinical trial safety
- Safety systems
- Global PV processes
- Regulatory compliance
- PV process and document management
- Cross-functional collaboration
- Training and communication
- Time management and organization
- Independent working and decision-making
- Interpersonal and communication skills
- Ability to work in a multicultural team
Job-Level Responsibilities
The role requires the ability to:
- Work and operate independently on assignments.
- Perform routine and non-routine tasks within procedures and processes.
- Participate in large projects.
- Make adjustments or changes to procedures, processes, and projects.
- Apply expert knowledge of relevant methods, techniques, equipment, and procedures.
- Provide advice to less experienced employees.
- Collaborate with supervisors and peers on complex decisions.
- Operate without direct staff supervision.
Application Details
