PV Scientist

　　Location United Kingdom

　　Requisition ID 2218

　　# of openings 1

　　Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1262)

　　Job Brief

　　PV Scientist

　　Amicus Therapeutics is a global, patient-dedicated biotechnology company focused ondiscovering, developing, and delivering high-quality medicines for people living with raremetabolic diseases.Position SummaryThe Safety Scientist plays a pivotal role within Global Drug Safety to ensure safety assessment for allAmicus products, in close collaboration with the product assigned Global Safety Lead (GSL). TheScientist is responsible for coordinating the aggregate review and reporting of safety data from varioussources as well as safety surveillance and risk management activities pertaining to assigned products.This includes:

　　• Oversight and maintenance of the aggregate report schedule in conjunction with global regulatoryaffairs (GRA) including tracking of aggregate safety report submissions;• Coordination and oversight of all aggregate safety reports for Amicus products (e.g., PBRER,PADER) including acting as point of contact between the vendor and Amicus for all outsourcedaggregate safety reports;• Author and coordinate development of Risk Management and Pharmacovigilance Plans (e.g., EURMP) for assigned products, including the management of Benefit-Risk assessments and safetylabelling;• Support outsourced signal management activities including signal detection and maintenance ofvendor signal management documentation such as signal management charter and signalingstrategy;• Coordinate and document internal safety management team (SMT) and safety review board (SRB)meetings.Roles and Responsibilities:1. Coordinate and track all internal Safety Management Team (SMT) and Safety Review Board (SRB)meetings and tasks; documenting SMT/SRB meeting minutes and communicating decisionsappropriately2. Oversight and maintenance of the aggregate report schedule in conjunction with global regulatoryaffairs (GRA) including tracking of aggregate safety report submissions.3. Coordination and oversight of all outsourced aggregate safety reports including PSUR, PBRER,PADER in collaboration with GSL & SMT stakeholders. PV Scientist acts as the main point ofcontact between Amicus and Vendor for outsourced aggregate safety reports.4. Author ad-hoc aggregate safety reports, safety surveillance and health hazard assessment reports, asneeded.5. GDS liaison with Quality Operations for product quality complaint reports and health hazardassessments.6. Coordinate and oversee external data safety monitoring board (DSMB) operational tasks, DSMBcontracting & liaise with internal Amicus stakeholders concerning DSMB recommendations/ datarequests.7. Support GSL with maintenance of safety sections of reference safety information documents such asthe investigator brochure (IB) and company core datasheet (CCDS).8. Support internal and external ad hoc safety queries/supplementary requests (e.g., medical informationrequests) and analyzing/summarizing safety data from various sources, as needed, in collaborationwith GRA/GMA9. Coordinate and oversee safety deliverables on behalf of GDS for new marketing authorisationsubmissions and variations e.g. clinical overviews, safety summaries, safety database outputs.10. Author risk management and pharmacovigilance plans (e.g., EU-RMP) and support implementationof product specific risk minimisation programs.11. Process owner/ SOP author for certain PV procedures relevant to role12. Undertake assigned process improvement projects as delegated and represent GDS on crossfunctional program/ corporate initiatives, as deemed appropriate13. Support PV vendor oversight tasks and PV operational activities as required e.g. maintaining GDS/product trackers14. Delivery of product PV training to relevant stakeholder/ vendors as necessary (e.g. investigator safetytraining)Requirements

　　Educational Requirements• Bachelor’s degree in a biologic/medical/clinical/nursing fieldProfessional Work Experience Requirements• Minimum 2-3 years’ experience in a pharmacovigilance scientific role and >5 years’ experience inpharmaceutical industry, clinical research or relevant scientific/ clinical fieldExperience and Skills• Experience with adverse event reporting/ processing• Strong medical PV writing experience preparing post-marketing safety reports or similarscientific/ medical reports.• Experience preparing Risk Management Plans and supporting clinical development activitiesdesirable• Strong analytical and problem-solving skills with attention to detail• Accountable and able to work independently, seeking advice as required.• Ability to interact effectively with colleagues from multiple disciplines, both within and outsidethe company, on a global basis.• Proficient with Microsoft Word, PowerPoint, SharePoint, and ExcelOther skills/Attributes• Project leadership skills with strong organizational and prioritization skills• Demonstrated alignment with Amicus Mission Focus Behaviors• Passion for rare disease and patient advocacy.Travel• Minimal travel expected (<5% time) to attend company/ project meetings and professionaldevelopment courses.We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunityfor all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities,pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, andcreativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” areinterwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, thesethree pillars are a touchstone for inspiration, guidance, and encouragement.Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, withoutregard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protectedveteran, disability status or any other characteristics protected by applicable federal, state or local law.

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