Location: Cambridge, Massachusetts 02142

Duration: 12 months

Reporting to the Principal/Sr. Principal/ Head of Medical Safety and Science group, DSPV, directs and/or executes all safety surveillance activities in collaboration with the Lead Safety Physician with a focus on the identification, evaluation of safety risks for assigned marketed and investigational products throughout the products' lifecycle.

The primary function of the Drug Safety & Pharmacovigilance Consultant is to actively support focus on patient safety by performing and contributing to safety monitoring, the aggregate review and reporting of safety information in support of regulatory and partner reporting requirements, as well as safety surveillance and risk management activities pertaining to products.

Active participation on DSPV safety surveillance teams and activities including performing case series review or review of tabulated data and prepare draft interpretation of reviewed data for identifying and assessing safety signals and adequately documenting discussions and conclusions
Project manage signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for DSPV Evaluation, and performing ad hoc analyses as required
Collaborate with and support study teams and other applicable functional area specialists including (but not limited to) Clinical, Medical, Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for marketed and investigational products to optimally support alignment in the understanding and interpretation of safety data.
Responsible for taking, circulating, and finalizing meeting minutes for relevant signaling meeting for their assigned product.
Manages and/or support other Sr. Consultant in managing context and timelines for periodic reports for the assigned products.
Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
Maintain knowledge in disease and therapeutic area aligned to compound responsibilities
May have direct report(s) and responsible for oversight and performance of their activities
Foster an environment of collaboration, team building, and continuous improvement. Team-focused and comfortable in cross-functional settings
Other functionality and assignments as mandated by business need

Basic Qualifications

Bachelor's Degree in Medicine or Pharm D.
Minimum of 6+ years post degree DSPV professional experience with minimum 4 years in Safety Consultant role.
Proficient in ARGUS database along with working skills in Adobe Acrobat, Microsoft Windows/Office/Word/Excel/PowerPoint.

Preferred Qualifications

4 years of experience in safety science role.
Competent knowledge of good pharmacovigilance practices. Competent knowledge of US and EU pharmacovigilance regulatory requirements.
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 desirable
Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes
Familiar with MedDRA coding and safety database systems

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