Global Safety Lead

Company: Amikids, Inc.
Location: Philadelphia
Posted on: February 26, 2021

Job Description:

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 development compounds.
• 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 labelling.
• Providing the medical safety content for responses to PV inquiries from regulatory authorities related and coordinating cross-functional input into any applicable regulatory documents where required
• Providing medical safety assessment for individual product quality complaints, associated Health Hazard Evaluations, product safety recalls and Dear Healthcare Professional letters/communications.
• 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 Health desirable.
  • Minimum of 3 years of clinical experience as a practicing physician.
  • 3-5 years pharmacovigilance experience including ICSR medical review, safety surveillance and periodic benefit-risk assessment.
  • 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 manner.
  • Excellent verbal and written communication skills, including formal presentations.
  • Proficiency in Microsoft Office suite.
  • Sound organizational skills with the ability to prioritize tasks/ deadlines.
  • 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 08540;
    • 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