Shared Inn and Sdea Expert

**Major duties and responsibilities**:

- To draft or to contribute to the drafting or revision of new or existing PV Requirements and ensures input of the relevant stakeholders under the supervision of a SDEA Manager
- To manage the Shared INN and SDEA Team Data Management policy about the content update and maintenance of the International Contract Database with consumer healthcare products PV Agreements contracts
- To manage the coordination and ownership of the lifecycle management assessment of the Business Agreements enabling business Plan continuity and compliance and resolution of potential gaps with KPis and Metrics dashboard
- To collaborate with other safety teams in charge of execution and monitoring of their provisions and providing expert advice and support like PV Agreement business reporting for ensuring that optimal and compliant PV obligations are executed as required
- To support and to deliver inputs during trans functional projects e.g. involving the PVA Team toolbox or organization, user specifications or technical requirements during projects involving the Shared INN and SDEA Team Tool box evolution as data database specialist
- To contribute to the revision of the QD System in the scope of the job description
- To prepare training materials and job aids as required (outsourcing)
- In this collaborative role, the Shared INN and SDEA Expert works with colleagues, management, SMEs, and other departments, ex. Clinical, Regulatory, GBU representatives, Business Development representatives to exchange relevant information to fulfill his mission and objectives.
- Ensure all PV requirements are correctly configured in the PV database
- Management Oversight of the Contract Management Database as per Business Plan both globally and locally
- Develop communication channels by involving SMEs as appropriate to develop effective and successful execution of the PVA Provisions
- Provide strategic advice /inputs follow up execution and planning to ensure that quality initiatives are implemented with success including governance, metrics and related KPIs
- Represent the PVA Team for the management use and evolution enhancements of the Contract Management database owned by business development
- Present and update the team with progress about projects updates, and quality initiatives, including to internal trans functional in house PV Meetings
- Supports audits and inspections and assists in answering requests. Also ensures that SMEs who will be interviewed during the inspections have received the appropriate preparation training in collaboration with the PV Quality Audit and Inspection Readiness team. He or She participates in the implementation of CAPAs which are related to PV Agreements.
- Ensure that Quality System documentation is kept up to date
- Promote and propose innovative business solutions in the frame of process improvements

**Skills and Education**:
**Education**:

- Certified degree in Health sciences (e.g., pharmacist/Pharm D/nursing degree) or equivalent HCP qualification or Higher degree (Ph.D.) with 5 or more years’ experience of pharmacovigilance particularly in large-structured and complex international business environment
- Good knowledge of product safety / medicinal products development in pharma companies either by education or experience

Required knowledge and/or experience:

- Experience working with Business development functions and has a knowledge of the different types of Business Relationships.
- Preferably sensitized or involved as a stakeholder during the execution and compliance monitoring of Business Partnerships. The Shared INN and SDEA Expert has by experience a good knowledge of European Good Pharmacovigilance Practices
- Knowledge of global PV regulations, PTC regulations
- Strong knowledge of the case management
- Knowledge of PV safety system

Knowledge, Skill, Formal Education & Experience Requirements (Minimum requirements for assignment to this job):

- Knowledge: The Shared INN and SDEA Expert implements quality improvements initiatives and sustains subsequent operational objectives under the supervision of the Shared INN and SDEA Team Head, ensuring that the department works according to the best working practices and efficiently, and the business at large, is updated with best up to date information. The Shared INN and SDEA Expert is knowledgeable about project management practices, development principles and LEAN methodology.
- Analytics: The Shared INN and SDEA Expert supports management in the measure of its effectiveness and compliance measures. In this analytical role, the Shared INN and SDEA Expert advises on best work options and actions as needed for reaching this goal.
- Education: The Shared INN and SDEA Expert has a good knowledge of product safety either by education or experience.
- Communication Skills: English communication skills, both in written and verbal forms, are a necessity for clear and concise conveyance of information and in