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 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 Responsabilità 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 Requisiti fondamentali annual premio scheme pension private medical insurance wellbeing programme flexible benefits programme remote work options

R&D Graps Affiliate And Partnership Oversight Unit Head

Responsabile del personale in cantiere

Persona o coppia per cura casa e giardino

Ricevi nuove offerte di lavoro

Collaboratore

BadanteTrieste