Reporting to the Pharmacovigilance ("PV") Operations (“Ops”) Lead. The PV Associate will collaborate closely with the PV Operations Lead to ensure Spark protects patients' safety by providing safety support for products in various stages of clinical development and follow them through their lifecycle and commercialization. The role will ensure compliance with drug products in clinical development and/or post marketing with activities aligned to the strategy, goals and objectives of the Pharmacovigilance function in compliance with company goals and objectives, and requisite global and local regulations and requirements. The successful candidate will have a good Pharmacovigilance operations and compliance knowledge including experience with global individual case safety report handling and management of external Pharmacovigilance service provider(s) to ensure Company business needs are met. The role will support the Pharmacovigilance leadership in assigned aspects of Company product programs.
• Support and oversee deviation documentation, training, and CAPAs.
• Assist with inspection readiness process for pharmacovigilance.
• Assist with audit/inspection responses from PV and vendor and evaluate proposed corrections, corrective actions, and or preventive actions for compliance with applicable regulations, guidelines, and Spark policies.
• Monitor activities of vendor and business partners to ensure adherence and compliance with applicable SMPs, KPIs/Metrics, and PVAs and other contractual agreements.
• Develop and participate in the preparation of PV specific metrics related to KPIs, Quality Investigations, CAPAs, audits and inspection outcomes.
• Assist in monitoring department adherence and compliance regarding training with SOPs, and other PV specific procedural documents.
• Monitor and maintain documentation for continuous improvement of compliance.
• May serves as primary day-to-day resource and contact for other functions for Pharmacovigilance operational activities
• Support Pharmacovigilance leadership in assigned activities and actively participate in daily Pharmacovigilance activities with a “can-do, hands-on, positive attitude
- Support vendor oversight of all case intake and processing activities:
- Case review
- Escalation of case level issues when necessary
- Support convention-related training delivery to vendor
- Support any queries on Intake, triage and data entry of ICSRs by vendor
- Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
- Ensuring that ICSRs and other safety related documents are exchanged within time frames agreed by Pharmacovigilance Safety Agreement
Process Development, Training, and Documentation
• Support authoring and reviewing departmental procedures and maintain audits and inspection readiness
• Author and develop any relevant SOPs/WI as needed for Pharmacovigilance compliance quality and monitoring
• Assist with training employees in overall pharmacovigilance and adverse event reporting
• Maintain good documentation practice for all safety operation documents
• Ensure the completion of periodic ICSR or SAE reconciliations
• Support the investigation of any discrepancies
• Support PV Ops Lead overseeing PV vendor on SAE reconciliation activities with the SAE information in the clinical database
Other PV tasks:
• Track daily ICSR incoming cases
• Manage and maintain Spark PV mailbox when needed.
• Assisting in writing Safety Management Plan (SMP) for all studies
Education and Experience Requirements
• Healthcare Degree required:
o B.S.N./R.N. orB.S. Pharm./R.Ph. (w/certification/licensure) orB.S./M.S. (Life Sciences) required; Pharm.D.,Ph.D. orother related advanced scientific degree preferred.
• Focus on pharmaceutical safety related areas
• Minimum of 8 years in biotechnology or pharmaceuticalindustry and minimum 3 years in compliance
• Expert knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally.
• Experience in quality systems, safety systems and tracking metrics, compliance monitoring.
• Direct experience with tracking, compiling, and analyzing quality metrics is must.
• Experience in drug safety databases such as Argus and ArisG, individual case processing, and MedDRA and WHO-DD coding.
• Experience in vendor management, SAE reconciliation, writing Safety Management Plan, and working with Clinical team is preferred.
• Interacts collaboratively and effectively in a team environment (Clinical Operations, Clinical Science, Data Management, Medical Affairs) and external vendors
• Experience providing guidance to team member(s)
• Values driven: Science dedicated to patients; Embrace open communication and debate; Trust, respect, and accountability
Key Skills, Abilities, and Competencies
• Thorough understanding of ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements, pertaining to adverse event assessment and reporting, and post-market safety requirements.
• Ability to analyze and interpret medical and scientific data.
• Excellent written and oral communication and influence skills, with the ability to inspire confidence and work successfully with varied audiences.
• Ability to follow guidelines and procedural documents (experience of working with SOPs preferred).
• Oriented to quality, attention to detail and accuracy.
• Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines.
• Ability to work both independently and in collaboration with others.
• Must be flexible and willing to take on administrative responsibilities.
• Good computer skills (Word, Power Point, Outlook email) and familiarity with safety systems.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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