Job Description

Pharmacovigilance Scientist

• At Client 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. 
• Client's strategy in CVMD focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across cardiovascular (CV) disease, diabetes and chronic kidney-disease indications.
• The patient-centric approach is reinforced by science-led life-cycle management programs and technologies, including early research into regenerative methods. 

Main Duties and Responsibilities 

• In this role you will be responsible in leading scientific, technical or drug safety input for a project, group of products, systems or processes across the CDS Regions.
• You will represent the Region, and Client externally where required.
• You may lead a group of Clinical Drug Safety colleagues to deliver a project and project manage across a number of groups and/or projects and use in depth knowledge of specific products, therapeutic or technical areas.
• Senior Patient Safety Scientists are also mapped to this job capsule. 
• 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