Associate Director, Pharmacovigilance Agreements, Processes, Partnerships and Contracts, Global Patient Safety
AstraZeneca

Gaithersburg, Maryland

This job has expired.


Job Profile: Associate Director, Pharmacovigilance Agreements, Processes, Partnerships and Contracts, Global Patient Safety

Work Location: Onsite with flexibility in Gaithersburg MD OR Waltham MA

Summary:

Initially, working with the Pharmacovigilance Processes, Partnerships and Contracts (PV P,P&C) Lead, ensuring the organized data collection programs and externally sponsored research programs belonging to Alexion, AstraZeneca Rare Disease maintain pharmacovigilance compliance to global regulations, guidelines, Alexion's SOPs and training requirements.

Role includes Corrective and Preventative Actions (CAPA) and compliance management responsibilities:

  • May also include Negotiating optimal safety agreements and contracts for Alexion and AstraZeneca Rare Disease whilst establishing excellent collaborations and maintaining positive working relationships with third party partners and internal stakeholders (i.e. Licensing Partners).
  • Through the use of governance, relationship management, standardization and alignment ensure delivery in the most efficient lowest risk manner.

Typical Accountabilities:

Organized data collection programs belonging to Alexion and AstraZeneca Rare Disease:
  • Collaborates with Alexion, Astra Zeneca Rare Disease Patient Support Programs, Market Research Programs, Global Access to Medicines, Health Outcomes Research and Externally Sponsored Research programs in the reporting of pharmacovigilance (PV) events to Global Patient Safety (GPS).
  • Provides ongoing training to Alexion personnel and vendors on the reporting of PV events.
  • Serves as a resource to Alexion personnel on the reporting of PV events.
  • Works with stakeholders to understand the program and identify pharmacovigilance requirements.
  • Supports GPS Local Safety Officers with pharmacovigilance language in Patient Support, Market Research Programs, Global Access to Medicines, Health Outcomes Research and Externally Sponsored Research programs agreements.
  • Provides subject matter expertise concerning interpretation and implementation of regulatory guidelines and company Standard Operating Procedures (SOPs) related to Patient Support, Market Research Programs, Global Access to Medicines and Health Outcomes Research programs.
  • Collaborates with the GPS Safety Science and Analytics team to provide configuration and regulatory requirements oversight for Patient Support, Market Research Programs, Global Access to Medicines and Health Outcomes Research programs and to ensure configurations are accurate within the safety system.
  • Ensures the tracking of all Patient Support Programs and Market Research Programs for pharmacovigilance purposes.
  • Serves as a resource to Alexion personnel on the reporting of PV events.

Corrective and Preventative Actions (CAPA) and compliance management responsibilities:
  • Support PVA managers with compliance queries liaising with partner and appropriate internal stakeholders to track until resolution.
  • Support PVA managers with quality issues and CAPAs liaising with partner and appropriate internal stakeholders to track until resolution.
  • Maintain and support data exchange tools used within the PVA Team.
  • Responsible for training new and existing members on compliance and CAPA process including Veeva.
  • Maintain collaborative relationships with Global Compliance and Inspection team.

Education, Qualifications, Skills and Experience Required:
  • A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
  • Experience in working cross-functionally
  • Leadership skills, including proven leadership of project teams experience
  • Thorough scientific knowledge, understand all aspects of regulatory, pharmacovigilance and partnership issues
  • Thorough knowledge of the drug development process
  • Good attention to detail with ability to work with a high degree of autonomy
  • Excellent computer and time management skills
  • Proven ability to collaborate and to work across cultures
  • Knowledge of AZ Business and processes
  • Relationship builder with ability to negotiate, influence whilst maintaining independent and objective view, conflict management and interpersonal acumen is also required
  • Able to work effectively as a member of a cross-functional or global team
  • Understanding of change management process
  • Maintains commitment to AstraZeneca Values and Behaviors
  • Fluent in receptive and expressive English language and in written communications

Preferrered Education, Skills, and Experience
  • MSC/PhD in scientific discipline
  • Knowledge of new and developing regulatory and pharmacovigilance expectations
  • Knowledge of existing AstraZeneca external alliances and collaborative projects
  • Knowledge of GPS and Regulatory operating model
  • Experience of working with third party suppliers.
  • Experience of working in a global organization, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry

AstraZeneca an Employer of Choice

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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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 authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


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