Senior Scientist, Pharmacovigilance

Alvotech; United States; À distance; USD 90 000 - 135 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Pharmacovigilance

Drug Safety

Clinical trial safety

Safety systems

Veeva Platform knowledge

Formation

Master’s Degree in pharmaceutical sciences or related fields

Outils

Argus

ARISg

Veeva Safety Vault/Docs

Description du poste

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 withinternational 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 inPharmacovigilance/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 withglobal 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.