BTW, thinking BIGLY AND WAY outside the (currently defined BOXES) AKA partnership interfaces are a required skillset:
Blarcasamine
Summary of Position
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 Responsibilities
Act as the both the Global Pharmacovigilance director and key contact point for regulatory authorities on PV related issues Build GPV leadership team to set up, select and onboard PV vendor/CRO and maintain an efficient PV system in compliance with national regulations Track and report any regulatory authorities or business changes impacting pharmacovigilance and support the development and implementation of procedures Serve 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 subjects Work 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 date Lead the creation and review of important PV documents such as DSUR, IB updates, Annual Safety reports Drive 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 required Lead 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/ECs Represent 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/inspections Ensure direct reports training records are up to date, including SOPs and yearly Pharmacovigilance refresher training Responsible 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 required Provide 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 EMA Have oversight of other programs like non-interventional studies, safety studies and local registries and websites Provide relevant information as needed for the compilation of the Pharmacovigilance Master File (PSMF) Support the development and maintenance of Safety Data Exchange Agreements Represent the US site in discussion of safety operation issues at global functional team meetings Help in generating and tracking KPIs in monitoring site/regional compliance. Ensure appropriate filing and archiving of Pharmacovigilance related documents is performed Requirements
Registered Nurse (BSN, MSN), relevant Master with previous PV experience, Pharmacists (RPh or PharmD), or Medical Doctor (MD, DO) 5 to 10 years’ related experience in a biotechnology or pharmaceutical company or CRO environment 5 to 8 years’ experience in Pharmacovigilance and quality assurance - tactical, operational and strategic capacities is preferred Strong 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 required Excellent verbal and written communication skills, proof reading and organization skills Comprehensive and working knowledge of Microsoft Outlook, Microsoft WORD, Excel and PowerPoint. Electronic document management experience a plus Ability to handle sensitive material in a confidential manner Strong attention to detail and follow-up skills Maintain a high level of diplomacy, discretion, maturity and sound judgement Must be flexible and willing to take on significant administrative responsibilities Must take initiative and have ability to work independently and as a team member, and helping wherever needed Must be able to create contingency plans to deal with possible challenges and roadblocks
Remote position; intermittently required to work on-site in New York City; occasional travel.
