Experteer OverviewIn 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 / BenefitsContribute 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
ResponsabilitàMaster 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 xysqume 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
Requisiti fondamentaliannual premio scheme
pension
private medical insurance
wellbeing programme
flexible benefits programme
remote work options
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R&D Graps Affiliate And Partnership Oversight Unit Head

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