Associate Director/Director, Drug Safety and Pharmacovigilance Operations and Systems

About the position We are seeking an Associate Director/Director, Drug Safety and Pharmacovigilance Operations and Systems to join our team. This important role in the Pharmacovigilance Operations (PV Ops) team will be responsible for the maintenance and oversight of appropriate procedures and systems to assure adherence to local and international regulatory requirements for collection, processing, and reporting of safety information throughout the product life cycle. They may be deployed to one or more of the key areas of process and performance excellence within the Pharmacovigilance Operations remit: safety report case management, quality & compliance, safety agreements, safety systems, and vendor management. This position reports to the Executive Director, Pharmacovigilance & Drug Safety Operations & Systems, and will be based out of Boston, MA, USA in our Needham office. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. Responsibilities • Act as a DSPV Operations study lead for case management including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training. • Assist with operational leadership for case management workflow, overseeing case processing activities and ensuring critical timelines and compliance metrics are met. • Collaborate with data management and other stakeholders as appropriate for safety data reconciliation; follows up to facilitate prompt resolution of any discrepancies. • Serve as a SME for DSPV compliance and inspection and audit readiness for case management- related topics. • Collaborate with DSPV personnel to prepare safety data listings and reports as needed. • Assist with safety database maintenance activities including but not limited to validation, data migration and associated change management actions. • Assist in management of PV mailboxes and distribution lists. • Monitor and ensure compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities). • Serve as a SME for PV compliance, PV Agreements, and inspection and audit readiness for compliance and quality related topics. • Author and maintain pharmacovigilance agreements, including but not limited to safety data exchange agreements, safety handling plans, and safety management plans. • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, applicable SOPs and WIs, other study plans, metrics, and contractual agreements. • Assist in development and maintenance of SOPs, WIs, and procedural guidance documents in collaboration with other functions. • Participate and lead, as appropriate, DSPV and cross-functional program team meetings and vendor oversight meetings where operational items are discussed. • Provide vendor oversight for the generation of validated safety reports from the safety database. • Collaborate with safety physicians and other members of DSPV, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing safety data outputs. • Assist in the preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports. • Prepare and provide training for DSPV team, PV and non-PV vendors, and safety reporting training at Investigator meetings as applicable. • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. • Other duties as assigned. • Some international travel may be required. Requirements • Health Care Professional degree preferred (e.g., RN/BSN/MSN, NP, PharmD). A Bachelor of Science Degree in Life Sciences combined with relevant experience will be considered. • Associate Director will have a minimum of a bachelor's degree with a minimum of 8+ years management experience in the pharmaceutical industry experience in drug safety & pharmacovigilance operations for products in the clinical trial and post-marketing environments or combination of degrees and experience. • Director will have a minimum of a bachelor's degree with a minimum of 10+ years management experience in the pharmaceutical industry experience in drug safety & pharmacovigilance operations for products in the clinical trial and post-marketing environments or combination of degrees and experience. A master's degree is preferred. • Five years of experience working with and providing oversight to PV vendors and/or hosting partners. • Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER). • Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance. • Knowledge of drug development process, pharmacovigilance databases and MedDRA coding. • Understanding of clinical disease state and implications of treatment. • At ease with data handling and visualization, statistics, and technical writing skills. • Experience with use of safety databases, preferably Argus Safety Database and data visualization/analytics applications. • Strategic critical thinking skills with focus on data integrity and high-quality outputs. • Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills. • Time management skills with ability to prioritize to meet required deadlines. • Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment. 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