• Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner.
• Management of external shareholders, license partners and vendors. Development and implementation of pharmacovigilance agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) as well as monitoring compliance to the mentioned PVAs and SDEAs.
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
• Provide oversight and review of vendor case processing and submission activities
• Review and monitoring of CRO compliance through various monitoring reports and other oversight activities such as tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database
• Manage SAE / SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements) and post marketing cases when applicable
• Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events
• Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance with data requests.
• Manage SAE reconciliation process with internal and external partners
• Assist in development, review and approval of search strategies for literature review
• Contribute and support safety monitoring and signal detection activities for products including overseeing report scheduling and deliverables for signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks.
• Support PSRT (program safety review team) quarterly and ad hoc analyses meetings including recording and approval of minutes.
• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements
• Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity. Communicates with partner companies and vendors regarding processing and timely exchange of safety data.
• Oversees distribution of aggregate reports as required and assists with reconciliation activities if needed.
• Develop and maintain Safety and Pharmacovigilance related documents including CRO Safety Management Plans, SOPs and Work Instructions, ESRP (PV expedited and periodic safety reporting plan) and Safety Data Exchange Agreements.
• Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
• Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
• Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc.
• Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed
• Support the development of PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
• Responsible for SOP development and facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
• Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
• Serve as member of PV QA team with support for external and internal audits and inspections

What we’re looking for

• BSN, PharmD or similar related scientific background
• 10+ years of directly related experience in Pharmacovigilance
• Experience working with and overseeing vendors and partners
• Proven history of successful interaction with internal and external stakeholders
• Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
• Experience completing successful PV data migrations is a plus

What will separate you from the crowd

• 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 collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Experience with safety database systems (ARGUS, Aris G)
• Proficient in standard computer software (Word, Excel and Power point presentations)

What you should know 

• The base pay range for this position at commencement of employment is expected to be between $210,000 to $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience