Beschreibung
For our customer, a global swiss pharma company with its` headquarter in Basel, we are looking for a
Drug Safety Licensing Associate (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM+
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- 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
Ihre Qualifikation
- 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
Skills:
- Drug safety associate
Keywords: Drug Safety Licensing PVA Pharmacovigilance Regulatory Affairs