Job Title

Anavex Life Sciences Corp. is seeking a talented and highly motivated pharmacovigilance director/Sr. director to join our team. This position will have full responsibility for Drug Safety activities for assigned projects in clinical trials. This includes meeting internal and external sponsor requirements according to time, quality, scope, and budget parameters. The Pharmacovigilance director is the primary point of contact for Drug Safety on a project, for internal project team members, sponsors, investigators, and vendors. This role encompasses the coordination of a variety of Drug Safety activities such as the collection, detection, assessment, monitoring, and prevention of adverse events and effects with pharmaceutical products. The role requires a careful and precision-based mindset that looks ahead to predict and prevent safety problems before they occur in clinical trials and other pharmaceutical related projects.Key ResponsibilitiesAct as the both the Global Pharmacovigilance director and key contact point for regulatory authorities on PV related issuesBuild GPV leadership team to set up, select and onboard PV vendor/CRO and maintain an efficient PV system in compliance with national regulationsTrack and report any regulatory authorities or business changes impacting pharmacovigilance and support the development and implementation of proceduresServe as a key liaison between the Global Clinical Team and third-party vendors for the management of adverse event reports from company sponsored clinical studies.Lead safety operations activities related to clinical trials, and closely interact with Research & Development stakeholders to ensure an appropriate safety monitoring of clinical trials subjectsWork in collaboration Global Clinical Operations to maintain the pharmacovigilance section of the Trial Master File/Sponsor Oversight Files to ensure sections related to clinical safety are accurate and up to dateLead the creation and review of important PV documents such as DSUR, IB updates, Annual Safety reportsDrive and support activities related to company sponsored clinical trials to provide required pharmacovigilance contributions such the drafting of Safety Management Plan (SMP), and the review of protocols, inform consent forms (ICF), and other clinical documents as requiredLead Global Pharmacovigilance and work with Global Clinical Operations, Regulatory Affairs, and Clinical Research Organization to ensure a timely submission of pharmacovigilance reports (SUSARs, DSURs, REMS, and other safety communications, etc.) to regulatory authorities and IRBs/ECsRepresent pharmacovigilance at a variety of business meetings, including project team meeting, vendor evaluation meetings, vendor oversight meetings, and other ad hoc meetings as assigned. Support audit/regulatory inspections and work closely with GPV leadership in the implementation and management of CAPAs following the audits/inspectionsEnsure direct reports training records are up to date, including SOPs and yearly Pharmacovigilance refresher trainingResponsible for receipt, timely forwarding, collection, and follow-up of individual case safety reports (ICSRs) as well as monthly reconciliation activities including maintenance of local site file/trackers when requiredProvide the needed support in the scheduling compilation and timely submissions of Periodic Adverse Drug Experience Reports (PADERS) and other aggregate safety reports to the FDA and EMAHave oversight of other programs like non-interventional studies, safety studies and local registries and websitesProvide relevant information as needed for the compilation of the Pharmacovigilance Master File (PSMF)Support the development and maintenance of Safety Data Exchange AgreementsRepresent the US site in discussion of safety operation issues at global functional team meetingsHelp in generating and tracking KPIs in monitoring site/regional compliance.Ensure appropriate filing and archiving of Pharmacovigilance related documents is performedPosition will be filled at level commensurate with experience.RequirementsMedical Doctor (MD, DO), with previous PV experience5 to 10 years' related experience in a biotechnology or pharmaceutical company or CRO environment5 to 8 years' experience in Pharmacovigilance and quality assurance - tactical, operational and strategic capacities is preferredStrong experience in the conduct and management of clinical trials, especially phase II and phase III clinical trials (CNS experience preferred but not mandatory)Personnel management and supervisory experience is requiredExcellent verbal and written communication skills, proof reading and organization skillsComprehensive and working knowledge of Microsoft Outlook, Microsoft WORD, Excel and PowerPoint. Electronic document management experience a plusAbility to handle sensitive material in a confidential mannerStrong attention to detail and follow-up skillsMaintain a high level of diplomacy, discretion, maturity and sound judgementMust be flexible and willing to take on significant administrative responsibilitiesMust take initiative and have ability to work independently and as a team member, and helping wherever neededMust be able to create contingency plans to deal with possible challenges and roadblocksLocationRemote position; intermittently required to work on-site in New York City; occasional travel.