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Sr, Manager/AD

2 months ago

Los Angeles, California, United States The Judge Group Inc. Full time
Location: REMOTE
Salary: $140,000.00 USD Annually - $170,000.00 USD Annually
Description: Our client who is working on CNS/psychiatric disorders is currently seeking a Sr, Manager/AD - PV and Safety

POSITION RESPONSIBILITIES:
  • Accountable for global oversight of drug safety processes and compliance, and drug safety deliverables.
  • Provides detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs).
  • Performs signal detection using the medical literature and relevant medical databases, as appropriate.
  • Medically reviews individual case study reports from clinical trials, as well as evaluates all relevant cases in depth, including MedDRA coding.
  • Performs regulatory assessment for expectedness and seriousness of AEs.
  • Oversees the delivery of Periodic Adverse Drug Experience Reports.
  • Accountable for SAE narrative generation; SAE database; and investigator alerts for clinical trials.
  • Ensures timely and appropriate drug safety contributions to NDA periodic reports.
  • Oversees the regular review of NDA safety data with respect to safety label updates and modifications.
  • Directs the creation and maintenance of company core safety information.
  • Reviews and approves safety sections of all clinical study reports (CSRs) (including interim as well as final reports).
  • Oversees the preparation of NDA documents, specifically the Integrated Summary of Safety (ISS) or equivalent document, and all safety related review comments or questions.
  • As needed, Develops and oversees Risk Minimization Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS).
  • Collaborates with cross functional team to develop Risk Assessment Plan, with continued monitoring throughout the development and life cycle activities.
  • Oversees development, implementation and reporting of pharmacoepidemiology studies when needed.
  • Responsible for the safety agreements with DR&PV vendors and clinical trial CROs.
  • Contributor to key clinical and regulatory documents such as Investigator Brochures (IBs), IND packages, and other safety documents to support CTAs, NDAs or Annual Reports.
  • Stays informed of new safety regulations and guidance from the regulatory authorities.
  • Manages pharmacovigilance provider; supports vendor identification and contracting as required.
CANDIDATE REQUIREMENTS:
  • Advanced Life Science degree required
  • A minimum 7 years combined in pharmacovigilance and clinical research/clinical safety experience in the pharmaceutical industry.
  • Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.
  • Knowledgeable in international regulations governing drug safety.
  • Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing.
  • Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
Contact:

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