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Drug Safety Licencing Associate (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support, Client

Projektbeschreibung

- Manage and oversee communications with license partners related to compliance projects, impacting compliance for the License Partners
- Responsible for writing Safety Agreements for any commercial arrangement and/or clinical studies/programs between the client and its partners as appropriate, via DSL templates, guidance's and standard operating procedures under the supervision of the DSL Manager
- Identify the license partners impacted by the compliance project and need to be informed
- Coordinate formulation of responses to be provided to license partners and track the questions and answers in a Sharepoint area
- Act as a single point of contact with the license partners for such compliance communications and keep the appropriate DSL colleagues informed
- Establish collaborative working relationships with key stakeholders and other compliance functions to ensure compliance with regulations as well as internal processes for Pharmacovigilance agreements
- Closely collaborate with internal and external contacts with respect to Pharmacovigilance issues related to commercial arrangements
- Draft new agreements based upon DSL approved PVA template and make amendments to existing agreements, under the leadership and mentorship of the DSL manager
- Ensure accuracy and up-to-date information of agreements in the Pharmacovigilance Tracking Database and DSL Shareweb and 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 to ensure understanding of and compliance with Safety Agreements
- Assist in Pharmacovigilance Inspection Readiness activities and in Pharmacovigilance audits
- 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
- Advise Manager/Head Drug Safety Licensing of unresolved problems/on-going issues regarding PVAs
- Assist in ensuring accurate and up-to-date information in contracts and agreements appendix of the Pharmacovigilance System Master File
- Bachelor's Degree in life science/health care (or equivalent through experience) with a proven experience in Pharmacovigilance
- Knowledge and understanding of FDA and ICH regulations and guidelines
- Proven excellent written and verbal communication skills with an international or cross-functional perspective, able to represent department 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
- Ability to simultaneously work on several projects at the same time
- 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

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    15 MM

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland

  • Projekte:

    1.364 Projekte Alle anzeigen