ASSOCIATE DIRECTOR/DIRECTOR - DRUG SAFETY/SURVEILLANCE
The Associate Director/Director of Drug Safety/Surveillance encompasses a key role in providing drug safety expertise and supporting the execution of departmental strategy and the day-to-day safety-related drug safety surveillance and risk assessment activities. Major areas of responsibilities include evaluating emerging safety data, identifying, and managing safety signal(s), authoring key sections of periodic safety reports and other PV documents, and providing safety support for clinical development. This position will report to the Vice President, Head of Drug Safety.
- Participates in the development and review of appropriate safety sections of key safety documents including: IBs (including RSI determination), protocols, ICF, CSRs, CCDS
- Lead strategic planning, and oversight, timely delivery of safety-related regulatory documents including the preparation of DSURs, IND Annual Reports, PSURs/PBRERs, and other global periodic safety reports
- Participates in and supports management of medical review of individual case safety reports (ICSRs/SAEs) for products throughout the life cycle, including review of SUSARs and IND Safety Reports, and including generation of Analysis of Similar Events as needed
- Perform ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports
- Signal Detection and Issue Workup: Supports identification and reporting on possible trends and concerns as they relate to Pharmaceuticals products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Review and summarize clinical safety data and draft safety sections for IB, ICF, company core data sheet, RMP, REMS
- Review and draft SAE narratives to support clinical development activities including CSR, interim analysis, business partner reports, review, and QC CSR safety sections
- Identify relevant safety data, conduct safety analysis and, evaluate, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
- Perform literature surveillance, identify safety issue from published medical literature, summarize relevant publications for inclusion in safety periodic reports
- Support projects or other initiatives from cross functional groups and departments (Clinical, Regulatory, Quality and Safety), ensure adequate safety support and timely update of safety information to key stakeholders
- Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational products and recommends changes and upgrades to existing departmental policies, SOPs, and systems
- Supports the development of Drug Safety infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
- May also participate in other activities as required to support the day-to-day functioning of the Drug Safety group
- Education: Master's in life sciences - PharmD, RPh, PhD, RN, PA
- Experience: minimum 5 years' experience in pharmacovigilance in a pharmaceutical or biotechnology company.
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment).
- Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize scientific data.
- Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
- Ability to work independently, to manage work priorities, to build to build collaborative team relationships at all levels and remain flexible to the needs of the teams/projects