Reporting to the Pharmacovigilance ("PV") Operations (“Ops”) Lead 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. S/he will serve as an operations associate in PV 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. Job Function and Description
PV team tasks:
- Manage and maintain Spark PV mailbox.
- Track daily ICSR incoming cases
- Track Aggregate Report
- Track SAE reconciliation
- Organize and write meeting minutes for PV team meetings and other meetings if needed
Vendor management support:
- Support vendor oversight of all case intake and processing activities:
•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 SAE Reconciliation:
- Support PV Ops Lead in overseeing PV vendor on Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database.
- Liaise between clinical team or their CROs and the PV vendor to resolve any issues from the SAE reconciliation
Represent PV to attend clinical meetings and manage clinical safety issues in the absence of PV Ops Lead. Aggregate reporting:
Support and assist PV Patient Safety Lead team for the preparation of DSUR/PBRER (PSUR) by delivering required documents or listings from the vendor. Quality and Document Management:
Process development and training:
- Investigate and input for late submission findings, ensuring resolution and preventive action, and implementation of correction action.
- Work collaboratively with QA team on managing deviations, CAPA, PV procedures and training for the PV department
- Maintain and track PV Internal compliance in relation to PV SOPs and PVA.
- Maintain quality issues by performing 5% Quality Review of internal PV Sponsor Reviewed ICSRs
- Monitor activities of vendor and partners to ensure adherence and compliance with applicable SMPs, PVAs, and other contractual agreements involved in ICSR submissions.
- Work closely with Clinical TMF staff and vendor in providing PV documents to designated TMF location for all Spark studies
Support authoring and reviewing departmental procedures and maintain audits and inspection readiness. PV Ops Lead Support:
Educationand Experience Requirements
- Assisting in writing Safety Management Plan (SMP) for all studies
- Organize and write meeting minutes for PV team for PV team meetings.
- Deputy PV Ops Lead in the absence of PV Ops Lead
Healthcare Degree required:
Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD) Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) Pharmaceutical industry experience is required with a focus on ICSR management (7 years minimum). Experience in drug safety databases such as Argus and ArisG, individual case processing, and MedDRA and WHO-DD coding. Global ICSR submissions experience required. Experience in vendor management, aggregate reporting, SAE reconciliation, writing Safety Management Plan, and working with Clinical team. 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-marketsafety requirements. Ability to analyze and interpret medical and scientific data. Ability to manage multiple priorities and work in a flexible, dynamic and fast-paced environment 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 etc 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 significant administrative responsibilities
- Good verbal and written communication skills
- Good computer skills (Word, 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.
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees. Nearest Major Market:
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
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