Position: Senior Drug Safety Associate
Location: Cambridge MA
The Drug Safety and Pharmacovigilance (DSPV) Group are seeking an experienced (senior) Drug Safety Associate (DSA). The Senior DSA will provide technical and process-related support for all as aspects of drug safety case management (processing and reporting) for investigational compounds and marketed products, while assisting with ongoing refinement of departmental strategy, activities and projects. In addition, this role may serve as a liaison to external stakeholders (Partners) on Safety related matters and policy including activities such as case management, compliance, Partner Pharmacovigilance (PV) agreements, aggregate reporting and global risk management of Ironwood products.
DSPV has a vendor to externally host its Ironwood Safety Database (ISD). The DSA will play a key role in supporting the existing implementation, legacy migration and business support model for an externally hosted Oracle Argus Safety System. The safety system enables the exchange safety data between multiple Partners and Regulatory authorities and supports DSPV in global responsibilities including aggregate data exploration, periodic reporting and data mining/safety signaling activities. The DSA role may assist with system validation activities as well as will provide input on continuous process improvement of the system’s functionality, system and business process change control, documentation of processes such as Standard Operating Procedures (SOPs) and update/development of training materials in accordance with relevant global regulations and SOPs.
Desired background, experience and capabilities:
- Scientific degreePharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience. Minimum 5 – 7years’ experience in Pharma industry with 3 -5years Drug Safety experience
- Knowledge and experienceworking with Oracle Argus is preferable
- Proven ability to work well with others in a proactive, positive, and constructive manner. A positive attitude for driving ambiguous situations.
- Analytical and organizational ability , able to prioritize with problem solving skills under minimal supervision
- Strong interpersonal skills and professionalism
- Ability to work independently, as well as within a cross-functional team environment
- Focus on detail with enthusiasm to constantly seek ways to improve processes and practice
- Ability to work in a dynamic environment and manage competing priorities
- Good clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way