Drug Safety Licensing Associate (m/f)

-Draft new agreements and make amendments to existing agreements, under the leadership and mentorship of the DSL manager
-Draft the agreement based upon DSL approved PVA template
-Coordinate input to agreement from concerned parties
-Compile agreements
-Co-ordinate review cycles and sign off
-Co-ordinate implementation of agreement
-Maintain and update existing agreements as necessary under supervision
-Ensure accuracy and up-to-date information of agreements in the Pharmacovigilance Tracking Database and DSL Shareweb
-Maintain status update of all agreements and DSL's PVA on-going worksheet
-Support the DSL team in managing the oversight of License Partner activities as per DSL guidance
-Serve as DSL resource for PDS and other relevant Roche functions to ensure understanding of and Compliance with Safety Agreements
-Closely collaborate with internal and external contacts with respect to Pharmacovigilance issues related to Commercial arrangements
-Advise Manager / Head Drug Safety Licensing of unresolved problems / on-going issues regarding PVAs
-Support the DSL team and Head of Drug Safety Licensing in ensuring all DSL guidance documents / work Instructions and standard operating procedures are up-to-date
-Assist in Pharmacovigilance Inspection Readiness activities
-Assist in Pharmacovigilance audits
-Establishes collaborative working relationships with key stakeholders and other compliance functions to ensure compliance with regulations as well as internal processes for Pharmacovigilance agreements
-Bachelor's Degree in life science / health care degree (or equivalent through experience) with a proven experience in Pharmacovigilance
-Assist in ensuring accurate and up-to-date information in contracts and agreements appendix of the Pharmacovigilance System Master File
-Actively emulates Company values in the team
-Establishes collaborative working relationships with key stakeholders, and internal and external customers
-Proven excellent written and verbal communication skills with an international or cross functional perspective, able to represent the company internally and externally
-Excellent command of English
-Knowledge and understanding of FDA, EU Pharmacovigilance Legislation and related regulatory documents, ICH guidelines and national/international GCP requirements
-Excellent problem-solving, analytical, impact assessment and strategic thinking skills.
-Detail oriented
-Ability to simultaneously work on several projects at the same time
-Good time management
-Solution oriented
-Demonstrated process improvement and change management skills
-Ability to collaborate and communicate effectively and efficiently in an international matrix environment

Weitere Qualifikationen: Drug safety associate