Associate Director, Pharmacovigilance Position Summary
Provide medical review and assessment of individual case safety reports created by a pharmacovigilance vendor. This includes review for seriousness, expectedness and AE coding, creation of follow up questions for each case. Requires minimum of three years concentrated experience with medical review and assessment. The Safety Physician will lead surveillance responsibilities, including interpretation and evaluation of aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations.
Roles and Responsibilities
Oversees the provision of medical assessments of product complaints and of all clinical and post-marketing adverse event case reports by CROs or business partners.
Execute the medical review of clinical trial SAE reports and all post-marketing
reports (narrative, coding, expectedness, causality, and company comment)
Provide medical queries for SAEs
Performs signal detection activities on adverse event data for all Amicus products in clinical development and Amicus marketed products and in consultation with the QPPV for products in territories outside the US;
Participates in the selection, implementation and maintenance of signal detection systems as needed;
Manages the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the risk management plans of marketed products.
Participates in the Safety Committee in maintenance of benefit risk profile of products in development and marketed products; responsible for the safety sections of Company Core Data Sheets (CCDS) and contributes to the safety sections of investigator brochures (IB).
Participates in labelling committees
Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
Manages adverse event coding using MedDRA including synonym maintenance in collaboration with Corporate Drug Safety Operations.
Reviews aggregate reports (PADERs, PSURs, PBRERs, DSURs);
Prepares, implements and maintains standard operating procedures (SOPs) and policies relating to pharmacovigilance (PV) and risk management to ensure compliance with regulatory requirements;
Develops and conducts training as necessary.
Participates in internal and external audits.
Responsible for assisting with remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits.
Minimum of 3-5 years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
Experience and Skills
Expert knowledge of FDA regulations, GVP in the EU, ICH guidelines, and other applicable regulatory guidance documents required
Experience with pharmacovigilance audit process. Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology preferred
Familiarity with common adverse event management databases (e.g. Argus) is preferred Knowledge of MedDRA and WHO Drug coding dictionaries preferred
Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting required
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way required
Comprehensive experience with obtaining, analyzing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports, is required
Excellent verbal and written communication skills, including formal presentations. Must have excellent written and oral communication skills, resourcefulness and personal organization skills. Proficiency in Microsoft Excel, PowerPoint and Word required
Sound organizational skills with the ability to prioritize tasks required
Excellent interpersonal, team management and leadership skills required
Amicus Therapeutics, Inc.