Global Safety Lead
Company: Amikids, Inc.
Posted on: February 26, 2021
Amicus Therapeutics is a global, patient-dedicated biotechnology
company focused on discovering, developing and delivering
high-quality medicines for people living with rare metabolic
diseases. The Global Safety Lead is a senior pharmacovigilance
expert (PV physician), who is responsible for asset safety
strategy, throughout the product lifecycle, for assigned marketed
products and development compounds. The Global Safety Lead is
responsible for supporting the safety elements of marketing
authorization applications, the product safety surveillance
strategy, risk management plan, risk communication including safety
labeling, medical assessment of individual adverse event reports,
review of aggregate safety reports, and defining the response
strategy to ad hoc regulatory safety requests. The Global Safety
Lead chairs and leads a cross-functional Safety Management Team
responsible for overseeing the benefit-risk profile of assigned
products and escalating significant safety concerns to the Amicus
Safety Review Board . He/she participates in due diligence
activities and special projects as needed. Roles and
Responsibilities The Global Safety Lead is responsible for:
- Medical safety review of all available safety data generated
from various sources (e.g. pre-clinical, clinical trial data,
post-marketing, literature) throughout the product life cycle for
assigned products. Medical review of adverse event reports includes
assessment for seriousness, expectedness, AE coding, company
causality and follow-up queries.
- Conducting signaling activities, including validation,
evaluation and risk communication/ PV planning in response to
confirmed safety risks.
- Leading the Safety Management Team (SMT) for assigned products
and managing benefit-risk profiles, including writing and updating
of the benefit-risk documents, for assigned products and
- Medical expert safety review and safety monitoring strategy for
assigned clinical development programs (e.g. protocol safety
language, ICFs, IBs, INDs, CTAs, DSURs)
- Lead preparation and review of Risk Management documents (e.g.
RMPs, REMS, risk minimization measures)
- Medical safety review and approval of PBRER and regional
periodic safety reports for assigned products.
- Providing expert safety input into clinical development
programs for assigned products.
- Safety representative at Labeling Working Group for assigned
products - partner with Regulatory and other R&D colleagues to
ensure accurate and up-to-date product safety information is
included in the RSI (IB/ CCDS) and other regional product
- Providing the medical safety content for responses to PV
inquiries from regulatory authorities related and coordinating
cross-functional input into any applicable regulatory documents
- Providing medical safety assessment for individual product
quality complaints, associated Health Hazard Evaluations, product
safety recalls and Dear Healthcare Professional
- Representing Global Drug Safety on leadership committees, both
internally and externally, as required.
- Participating in GvP audit/ inspection readiness activities for
PV-related activities for assigned products
- Continuously accruing therapeutic area knowledge to allow for
ongoing safety assessment within the therapeutic area, including
competitive products and therapies.
- Dual reporting to the SVP of Clinical Research (line
management) and Head of International Safety (functional
management) Qualifications and Background Requirements
- Medical degree (MD or equivalent).
- Post-grad qualification in Pharmaceutical Medicine or Public
- Minimum of 3 years of clinical experience as a practicing
- 3-5 years pharmacovigilance experience including ICSR medical
review, safety surveillance and periodic benefit-risk
- Expert working knowledge of FDA PV regulations, GVP, ICH
guidelines, and other applicable regulatory PV guidance.
- Ability to write SOPs and other working practices within the
context of clinical and post-marketing drug safety reporting.
- Familiarity with common adverse event management databases
(e.g. Argus, ARISg).
- Knowledge of MedDRA and WHO Drug coding conventions.
- Excellent clinical judgment and ability to communicate complex
clinical safety issues in a scientifically sound and succinct
- Excellent verbal and written communication skills, including
- Proficiency in Microsoft Office suite.
- Sound organizational skills with the ability to prioritize
- Excellent interpersonal, team working skills
- Prior experience of regulatory PV inspection, interactions with
regulatory authorities and risk management planning advantageous.
Location This position will be based at:
- Amicus Therapeutics, 600 College Rd E, Princeton, NJ
- or at Amicus Global Research and Gene Therapy Center of
Excellence, 3675 Market200 Philadelphia, PA 19104.
Keywords: Amikids, Inc., Philadelphia , Global Safety Lead, Other , Philadelphia, Pennsylvania
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