Lediga jobb som Kemikalieinspektör i Mölndal

Patient Safety Team

Hays Specialist Recruitment is now looking to recruit 2 Senior Safety Scientist to join the Patient Safety Team for 1-year contract assignment at AstraZeneca in Gothenburg.

At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building a culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organization dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world.

Introduction:
The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.

Main Responsibilities:

* Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
* Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
* Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
* Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
* Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
* Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
* Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
* Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
* Trains and mentors' junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Requirements - Education and Experience

* A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
* Fluent in written and verbal English
* Advanced knowledge of PV regulations
* Intermediate understanding of epidemiology preferred Visa mindre

Compliance Lead

Hays Specialist Recruitment is now looking to recruit a Compliance Principal / Compliance Analyst to join the QPPV&PV; Excellence Team in Patient Safety Centre of Excellence for a 6 month contract assignment at AstraZeneca in Gothenburg.

Job Description
Working with Compliance Lead in the QPPV&PV; Excellence Team in Patient Safety Centre of Excellence, in Chief Medical Office (CMO), taking responsibility for the management of assigned AstraZeneca projects and partnerships including: quality and compliance monitoring, data analytics to identify root causes and continuous improvement. Accountable to develop relationships across CMO and other relevant AZ functions, to execute the delivery of the QPPV&PV; Excellence continuous improvement strategy and priorities.

Responsibilities

* Drive a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches, across the AZ Pharmacovigilance (PV) system.
* Provides analytical support for Pharmacovigilance Compliance Systems.
* Provides expertise and resource for the design, development, implementation and continuous improvement, of a global portfolio of compliance analytics tools and reports.
* Supports the existing portfolio of reports/dashboards across various technical platforms (Spotfire, Oracle APEX, Excel VBA), further developing them and providing customer support.
* Provides analytical input where required to KPIs, internal and external benchmarks, compliance and data quality issues, as well as responding to ad hoc business requirements, including requests in support of regulatory inspections.
* Leads and/or contributes to specific projects/workstreams as required, to ensure full exploitation of compliance data.
* Acts as a key interface to customer groups and process area leads, both within and outside of Patient Safety (e.g. Operations), to understand reporting/analytical requirements and to develop technical solutions to meet those requirements.
* Provides data modelling support, specifically with a view to integrating data across Pharmacovigilance Systems
* Working with Patient Safety Process and Partnerships Leads and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to pharmacovigilance data reporting.
* Manage relationships/partnerships/alliances external to the CMO function that are essential to delivering AstraZeneca's pharmacovigilance License To Operate responsibilities, e.g. with AstraZeneca affiliates.
* Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.

Education, Qualifications, Skills and Experience
The following is highlighted:

* Technical skills in the following areas - Excel (incl. VBA), , Python, visual analytics (Tibco Spotfire or similar)
* Proven competence in the development of tools and methods to exploit data in support of business decision making including data modelling, data integration (ETL)
* Proven analytical ability to interpret and integrate complex data sets and communicate them effectively.

Desired qualifications

* Strong desire to move into a technical data/analytics role
* Awareness of wider IS developments within AZ or the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions, data integration systems and practices, etc.
* Able to work independently to solve complex problems, often while working with uncertain assumptions.
* Highly developed conceptual and analytical thinking, with ability to understand multiple, complex business needs.

Desired background

* Bachelor's/Master's degree or equivalent qualification in computer science or scientific discipline
* Experience working within a regulatory environment with an understanding of regulatory processes and systems Visa mindre