Senior Scientist, Pharmacovigilance

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.