layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

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Contractor – Senior Drug Safety Specialist at Syndax Pharmaceuticals | LAYIQ

Serve as PV operations lead for assigned clinical trials
Conduct the review of all domestic and foreign SAE reports for all Syndax investigational and post marketed products to make sure all important SAE elements are provided.
Ensure consistency in initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.
Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.
Perform quality reviews of completed SAE reports received from contract drug safety vendors (CROs); transmit reports to Syndax business partners per timelines in safety data exchange agreements.
Exercise judgment and apply knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments of expectedness.
Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information; work with the CRO to determine when cases are complete and ready to close.
Collaborate with Regulatory personnel to communicate reporting of SAEs requiring expedited submission to Regulatory Authorities and to ensure appropriate reporting is performed per timelines.
Collaborate with cross-functional teams, Clinical Operations, Data Management and Biostatistics; participate in meetings and teleconferences with cross-functional teams, CROs, and business partners.
Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.
Deliver weekly or monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines. Support supervisor with other SAE reporting and Pharmacovigilance Operations.
Inform Manager/Director of safety related issues and potential trends and or signals arising from review of pre and post marketed safety data.
May assist in the preparation of safety sections for regulatory documents and in developing Safety forms, standard operating procedures, and process guidelines.
May assist in signal detection activities and provide line listings for review.
Should be able to perform case deletions in the safety system if needed.
Familiar with SAE reconciliation process.
Support and participate in audits and inspections, including preparation activities.
Conducts literature searches to ensure the most current and appropriate literature is cited in the materials and to maintain product expertise.
Review published scientific literature for ICSRs pertinent to Syndax products
Provide oversight and management of multiple vendors
Desired Experience/Education and Personal Attributes: Bachelor's Degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
At least five years of progressive drug safety experience in a biotech/pharma company.
Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
Experience in SAE case-processing and working with safety databases.
Basic knowledge of MedDRA coding.
Proven knowledge of Good Documentation Practices and cGXPs.
Proficient in MS Office Suite.
Excellent written and verbal communication skills; fluent in medical terminology.
Ability to interpret and follow regulatory guidelines.
Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines.
Willing and able to work independently and in a collaborative team setting.
Location
: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.

Contractor – Senior Drug Safety Specialist

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