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.