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