Our Gaithersburg, Maryland facility creates life-changing medicines for people on a global level. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brainstorming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency 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.
Main Responsibilities:
You will recruit, develop, and lead a team of pharmacovigilance scientists and staff, and will provide expert oversight of Safety Strategy and Management Team (SSaMT) input to drug programs, and delivery of critical PV outputs. You will apply your expertise to assure quality deliverables, such as Periodic Reports (PBRERs and DSURs), Health Authority queries, PRAC responses, BLA/NDA/MAA filings, Risk Management Plans, etc. As a change management leader, you will lead and implement strategic change projects across Chief Medical Office Patient Safety therapeutic areas.
In addition, you will:
Develop objectives for Patient Safety in area of responsibility and ensure these are aligned to broader AstraZeneca goals and objectives.
Be an SME for PV regulations/mentorship, leading the Patient Safety Therapy Area
Represent and serve as a PV specialist in regulatory agency inspections
Share standard methodology across teams within the PS TA and between PS TAs, partnering with other groups as needed
Lead PS input into PV Agreements, managing alliance partners for assigned products; may lead due diligence activities
Provide strategic safety leadership for complex and ground breaking projects to improve processes within Patient Safety and/or develop and introduce new technologies and approaches at the national, regional or global level
Build networks with other PS TAs/teams and external partners to learn about new developments, create opportunities and share best practices, such as benchmarking and Industry forums
Partner with PS Center of Excellence to implement changes in PV legislative landscape to prepare appropriate resources and skillsets to address the future
Serve as deputy for TA PS VP or Platform Head
Participate as a member of the TA Leadership team
Minimum Requirements:
Master’s degree or equivalent qualification in relevant scientific field
10+ years of experience
Experience in managing a scientific team.
Extensive proven experience in Pharmacovigilance field
Knowledge of relevant legislation and developments in the Pharmaceutical industry
Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man
Experience leading strategic projects (Drug and non-drug)
Demonstrated ability to influence key partners within and outside of company
Demonstrated proficiency with both written and verbal communication
Desirable
PhD in relevant scientific field
Strong network and reputation within the business and industry
Extensive knowledge of the latest technical and regulatory expectations
