Overview
In this role you will coordinate SDEA and related contracts to ensure patient safety and global regulatory compliance. You will partner with business development, alliance management and legal teams to identify contracts needing SDEA development, acting as the main contact for SDEA/ICA matters and contract guidance. You will lead audits/inspections as SME, manage CAPA actions, and keep SDEAs current with timely renegotiations. You will support process documentation and Governance activities within the global safety framework.
Retribuzione / Benefits
- annual bonus scheme
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- remote work options
Responsabilità
- Contribute to the strategy for SDEAs and Intracompany Agreement program management
- Build collaborative relationships with business development, alliance management and legal to identify contracts needing SDEA development
- Act as main point of contact for SDEAs, ICAs, and license partners; advise on contract generation with Head of Affiliate Network
- Interface with contractual partners on issues throughout project lifecycles
- Serve as primary SME during audits or regulatory inspections; coordinate CAPA actions
- Ensure SDEAs are current; initiate renegotiations or terminations as needed
- Coordinate audit strategy with R&D PV QA
- Author or contribute to SDEA procedures and maintain templates
- Maintain tracking tools for SDEAs and update PSMF annexes
- Organize the periodic Global Safety and Compliance Council with the Compliance and Process Unit Head
Requisiti fondamentali
- Master Degree in life sciences, pharmacy or related fields
- Minimum 5/7 years of international Pharmacovigilance experience in Pharma/Biotech/CRO
- Excellent communication, interpersonal, negotiation and leadership skills
- Proven ability to manage contracts and handle multiple tasks
- Strategic thinking, problem solving and decision-making skills
- Strong planning, organizational and analytical abilities
- Ability to work with cross-functional teams with a result-oriented approach and attention to detail
- IT skills: Office package; safety database and other data management systems
- communication
- interpersonal
- negotiation
- regulatory safety information management (domestic and international)
- Pharmacovigilance alliance management
- knowledge of global regulations (GCP, GPvP) policies and legal requirements
R&D GRAPS Affiliate and Partnership Oversight Unit Head datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
