R&D GRAPS Affiliate and Partnership Oversight Unit Head

Experteer 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 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 life cycles

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 QAAuthor 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 Responsabilità

Master Degree in life sciences, pharmacy or related fields

Minimum 5/7 years of international Pharmacovigilance experience in Pharma/ Biotech/CROExcellent 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 detailIT skills:
Office package; safety database and other data management systems

Requisiti fondamentaliannual bonus schemepensionprivate medical insurancewellbeing programmeflexible benefits programmeremote work options
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