Pharmacovigilance Scientist
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Pharmacovigilance Scientist – in Gaithersburg, MD , you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca holds a unique position in Respiratory Disease , including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis.
Requirements:
Main Duties and Responsibilities
As a Pharmacovigilance Scientist you will participate in the triage process for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information. You will request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes. You are responsible to review adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA. You will lead teams in preparing, organizing, and reviewing tabulations for Regulatory reports. You assume responsibility for completing special projects (i.e. IND Annual Reports, PSUR table preparation). You support Safety Surveillance, Safety Support – Compliance and Marketing Company and the US Clinical Teams. You serve as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues. You are responsible for reflecting the Patient Safety philosophy of being a team player and supports the development of those individuals within the department. You will initiate special projects and demonstrate leadership capabilities at target level or above
Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Essential Requirements
•Bachelor's degree in science / healthcare related field or proven Patient Safety experience equivalence in a similar role with an excellent clinical background. Advanced degree is preferred
•Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
•Broad competence with medical, therapeutic and technical terminology
•Able to work effectively as part of a cross functional team
•Excellent verbal and written communication skills
Desirable:
•Demonstrated capabilities in: Project management, Time management, Presentation skills, Strong attention to detail and organization
•Demonstrated ability to perform with minimal supervision
•Works as a team player and supports the development of other team members
•Excellent knowledge of AstraZeneca policies, procedures and guidelines
•Provides training and mentoring of Patient Safety Coordinators on local and global adverse event reporting and with respect to career development
•Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues
•Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers
•Assumes a lead role in the interview process for prospective new team members
•Demonstrates an active interest in pursuing continuing education within the Pharmaceutical Industry
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.
