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Career Openings


Pharmacovigilance Scientist

ID: 1440
Department: Drug Safety
Location: Cambridge Headquarters
# of Openings: 1

Description

Position Summary:

The Pharmacovigilance Scientist (PVS) works closely with the Sr. Medical Director and the Drug Safety Physician to provide scientific/clinical expertise, support deliverables generations and activities associated with signal detection. This role contributes to the preparation of safety and benefit-risk evaluations for the assigned products, the management of potential safety issues, evaluation of databases for safety signals, and other activities such as drafting of responses to regulatory inquiries on product safety issues. In collaboration with the Sr. Medical Director, the PVS will have the following specific responsibilities:

 

Clinical Trial Safety:

  • Review study protocols, statistical analysis plans, and other clinical study-related documents
  • Review standard design of tables, figures and listings for safety data from clinical studies.
  • Contribute to the assessment of clinical trial vendors for outsourcing projects and communicates business needs effectively to PV management
  • Develop Safety Management Plans for Clinical Trial programs
  • Performs detailed vendor oversight activities including review of metrics, and deliverables from vendor
  • Reviews, documents, and escalates concerns and issues to PV management

 

Signal Detection, Evaluation, and Management:

  • Performs proactive safety monitoring and signal detection for assigned products
  • Completes initial assessment of safety signals and prioritizes safety signals for full evaluation
  • Draft the evaluation and prepare response documents of safety signals to answer internal and/or external requests
  • Perform case series review or review of tabulated data and prepare interpretation of reviewed data
  • Provide support for the cross-functional team responsible for overseeing the safety of Ironwood products in development and post-approval.
  • Maintain schedules, minutes, tracking sheets and ensure follow-up of decisions and assigned tasks
  • Assist in the preparation of presentation materials, documents and white papers when needed, including documentations supporting the decision process through the established safety governance model in place at Ironwood

 

Risk Management and Minimization:

  • Draft section(s) of the initial Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) for assigned products, and oversee the maintenance of these documents

 

Periodic (Aggregate) Safety Reporting:

  • Coordinate the activities related to the aggregate report preparation with other functions involved
  • Provide input into the preparation and coordination of assigned aggregate reports (i.e., PBRER, DSUR, IND annual, NDA annual, etc.) for submission to the health authorities and other stakeholders
  • Provide assistance with the preparation of white papers to address specific safety issues when needed.

 

Submissions and Other Regulatory Filings

  • Assist in the preparation of safety assessments and evaluations for ad hoc regulatory safety reports such as responses to health authorities’ requests, Health Hazard Evaluation, and responses to inquiries from internal and external customers
  • Provides PV input to the development of product Reference Safety Information (Core Company Safety Information, US Package Insert, Developmental Core Safety Information, Investigators Brochure, etc.), Summary of Clinical Safety, Integrated Summary of Safety, etc. in collaboration with the responsible Drug Safety Physician

 

Minimum Basic Qualifications:

  • Pharmacy degree with 3 years of PV experience, or MS in health-related field or BSN with 3 years of PV experience, or BS in life sciences related field with 5 or more years PV experience.
  • In depth understanding of medical terminology
  • In depth knowledge of global clinical and post marketing safety regulations, guidances, and reporting processes
  • Must be detail-oriented and must have strong organizational and communication skills
  • Experience with MedDRA coding and safety database systems

 

Preferred Qualifications and Experience:

  • At least 3 years of biotech/pharmaceutical industry experience, including at least 2 year of experience in clinical safety / Pharmacovigilance.
  • 3 years relevant clinical safety, regulatory, or risk management experience strongly preferred
  • Knowledge and experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses
  • Experience in the review of relevant safety information from all sources and analysis of safety data.
  • Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies

 

Competencies:

  • Ability to leverage a deep understanding of oneself through knowing one’s strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one’s effectiveness
  • Ability to recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance
  • Ability to focus on delivering excellent results and improving the performance of oneself and of Ironwood by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one’s own past performance, excel at an objective measure or goal, or do something that has never been done before
  • Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
  • Ability to express ideas and information clearly and accurately. Excellent interpersonal, communication, and personal organization skills;
  • Ability to targeting one’s efforts on discovering and meeting an internal or external customer’s needs by ensuring timely follow through to customer inquiries or business issues, and being proactive in adding value to the customer.

 

Work Environment:

  • This is a Cambridge-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Ironwood established policies and procedures and ensures alignment of their work with Ironwood's values.

 

Physical Demands:

  • Minimal travel may be required


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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