Pharmacovigilance Business Relationship Lead
Business Relationship Lead
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the Group:
The candidate will be a part of AstraZeneca Chief Medical Officer office supporting Patient Safety in the negotiation of new business deals. These include mergers, acquisitions and divestments of products and companies. This role is placed within the Patient Safety Center of Excellence – more specifically within the Process, Partnerships and Contract area.
Main Duties & Responsibilities :
- Ensuring global PS expertise and support in the delivery of strategic and business objectives in the Special Relationships Alliance area
- The role holder will work with the Safety and Regulatory Managers in the AZ subsidiary companies, AZ project teams across CMO, Specialists/Leads in other CoE areas, TA Specialists and Physicians, Clinical Alliance Leads and Clinical project teams, Legal, business development, and IS/Systems teams :
- to ensure effective, efficient and appropriate reporting of adverse events
- to leverage and align existing AZ infrastructure for in-licensing of new products/portfolios or transition of products across subsidiary/AZ partnerships, and look to ensure optimized operating models and processes to deliver robust compliance and mitigate risks (eg. new clinical partnerships and collaborations)
- to support a pharmacovigilance regulatory knowledge base strategy for AZ in regard to Regulatory Authorities across AZ/Subsidiaries, Clinical collaboration partners and/or other Special Relationships, as outlined by Special Relationship Lead, to ensure maintenance of a state of inspection readiness
- The role holder will provide support to Special Relationship and Acquisition/Divestment customers, and/or those requiring data to ensure PV needs are met in relation to AZ inspections.
Education & Experience Requirements:
- Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background with proven competence in Patient Safety/Clinical Development
- The ability to travel both domestically and internationally
- Proven project management skills and experience managing and controlling large projects /programs
- Demonstrated understanding of quality and compliance
- Excellent communication, relationship management, and influencing skills
- Understanding of contracts and transition service agreement language
- The candidate must have background in Pharmaceutical development and be familiar with US and EU regulations. Proven track record negotiating across complex groups
- Experience working in global organization and across cultural boundaries where stakeholders and project team members are geographically dispersed
- Strong knowledge and experience with Patient Safety or Regulatory systems (Life Science - pharmaceutical software)
- Excellent business acumen with sensitivity to environment
- Able to represent AstraZeneca externally where required
- Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours
- Self-starter, motivated and positive with ability to work with a high degree of autonomy in a dynamic environment.
- Long term vision – strategic thinker.
- 3-5 years Alliance management, and 5-7 years Global Regulatory, Patient Safety and/or Clinical Development experience
- Experience leading inspections/inspection activities
- Excellent knowledge of Regulatory Environment (e.g. FDA, MHRA, EMEA, other key markets/areas)
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.