Drug Safety Specialist
About the position The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for all patient’s receiving Verastem manufactured products. This is done by ensuring that the safety profile of Verastem products remains accurate and up to date throughout the product life cycle of development and through the following core activities: Relevant safety information including reports of side effects is collected and analyzed. Possible safety signals are carefully validated and characterized. Strategies are implemented to minimize risks and to ensure that products are used in a way that maximizes benefits and minimizes risks. Key among these is to ensure that accurate and up-to-date information on the safety profile of Verastem products is available to patients and prescribers in a timely manner. Communication with patients, providers, regulatory agencies, and other concerned bodies is essential to this effort. This includes developing and updating the investigator brochure, and protocols as well as any adjunct information for patients and health professionals. This information must be kept current throughout the life cycle of each product. Reporting to the Vice President, PV Operations and Compliance, Drug Safety Specialist contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with SOPs and policies, best industry standards and applicable regulations.
Responsibilities
- Participated in Adverse Event/Serious adverse event processing and reconciliations by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of Individual Case Safety Report reporting within the Company Sponsored Safety Database.
- Supports monitoring of Quality of vendor of Individual Case Safety Report processing for clinical and post marketing cases.
- Supports the monitoring and performing of notification and/or submissions for Individual Case
- Distribute Safety reports to clinical team, maintain the master contact list, oversee IST reconciliation
- Perform QC of SAE and non-serious AE cases as part of vendor oversight
- Assist with organization and preparation for FDA audit
- Prepare gap packs for clinical sites
- Additional safety related duties assigned.
Requirements
- Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences.
- Minimum of 3 years of Drug Safety/Pharmacovigilance case process in a pharmaceutical industry setting.
- Previous experience with ICSR workflow steps and Safety database (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.
- Strong analytical skill with superb attention to detail, and able to organize workload to prioritize most urgent deliverable.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment.
Benefits
- In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.