Drug Safety Specialist

Role Summary

Drug Safety Specialist contributes to day-to-day pharmacovigilance operations, ensuring the safety information for Verastem products is collected, analyzed, and kept up to date throughout the product life cycle, and that activities comply with SOPs, policies, and regulatory requirements.

Responsibilities

• Participated in Adverse Event/Serious Adverse Event processing and reconciliations by outsourced vendors, including review of ICS processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of ICS reporting within the company safety database.
• Supports monitoring of quality of vendor ICS processing for clinical and post-marketing cases.
• Supports the monitoring and performing of notification and/or submissions for Individual Case Safety Reports.
• Distribute safety reports to the clinical team, maintain the master contact list, and oversee IST reconciliation.
• Perform QA/QC of SAE and non-serious AE cases as part of vendor oversight.
• Assist with organization and preparation for FDA audits.
• Prepare gap packs for clinical sites.
• Additional safety-related duties as assigned.

Qualifications

• Minimum of 3 years of Drug Safety/Pharmacovigilance case processing in a pharmaceutical industry setting.
• Previous experience with ICSR workflow steps and Safety databases (Argus preferred), MedDRA coding and data entry experience and data entry conventions.
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Global pharmacovigilance operations experience with products in development.
• Knowledge of ICH Good Pharmacovigilance Practices and Good Clinical Practices.
• Anticipate and proactively resolve issues when and where possible.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.

Skills

• Strong analytical skill with superb attention to detail, and ability to organize workload to prioritize the most urgent deliverables.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively and collaboratively in a fast-paced team environment.

Education

• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences.