Senior Scientist, Pharmacovigilance
# Senior Scientist, Pharmacovigilance **Alvotech** · India · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Pharmacovigilance-Specialist]` `[Drug-Safety-Specialist]` `[Safety-Scientist]` `[Pharmacovigilance-Lead]` `[Senior-Scientist-In-Pharmaceutical-Sciences]` --- ### About the Role 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 great 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, 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 Key responsibilities and minimum requirements according to job level: - Works and operates independently on assignments - Performs both routine tasks within procedures and processes and non-routine tasks. - Takes part in large projects. - Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees. - Can make adjustments/changes to procedures, processes and projects. - Can have financial impact through decision making. - Expert knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge. - Is often advisory to other less experienced employees. - Collaborates with supervisor and peers on complex decisions. - Does not supervise staff. Competencies required to fulfill the employee responsibilities and work assignments: - An employee shall follow the job description that pertains to the position. In addition, an employee shall follow the SOPs that pertains to the position. - An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado. Originally posted on Himalayas
- Pharmacovigilance-Specialist
- Drug-Safety-Specialist
- Safety-Scientist
- Pharmacovigilance-Lead
- Senior-Scientist-In-Pharmaceutical-Sciences
Наблюдалась 2026-10-08, впервые 2026-10-08, источник — Himalayas (JSON API).