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PV Scientist

Cambridge, MA

Posted: 09/12/2019 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2391

Reporting to the (Sr.) Director of PV Science, Quality and Infrastructure (PV-SQI), the PV Scientist will play a key role in DSPV. The PV Scientist contributes to the day-to-day operational activities of the function of PV-SQI (and as needed PV Operations) and ensures that performed tasks comply with DS and PV SOPs and policies, best industry standards and applicable regulations.

  • Signal Detection and Aggregate Analysis:
  • Provide (safety-related) analysis (ad-hoc or planned) including literature search and analysis.
  • Conduct signal detection and risk management planning activities to support Global Safety Officer.
  • Project lead and authoring of periodic safety reports (e.g., DSUR, PSUR, PBRER)
  • Lead responses to regulatory queries in conjunction with Safety Physician
  • PV Quality:
  • Monitors compliance with regulations, PV agreements and internal SOPs.
  • Review and monitoring of compliance through various monitoring reports and other oversight activities. Ensures the implementation of effective corrective and preventative action plans.
  • Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
  • Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
  • Performance management of PV systems.
  • Participates in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections; prepares responses to audit findings that concern the DS and PV department.
  • Ensures compliant exchange of safety data between Client Company and its partners.
  • Other Activities:
  • Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
  • Provides safety operations support in daily case processing, tracking of (S)AE queries and SUSAR cases.
  • Participates and project management of Safety Data Management for established SDEAs.
  • Participates and project management of any safety related systems (e.g., ARGUS, ARISg, Signal detection system).

Requirements / Qualifications:
  • Bachelor’ s degree in nursing, pharmacy, or other health care related profession or life sciences required.
  • Master’ s or Doctorate level degree in health care related profession preferred, but not essential.
  • Minimum of > 3 years of experience in drug safety/pharmacovigilance in a pharmaceutical industry setting or the equivalent.
  • Global pharmacovigilance operations experience with products in development and/or post market.
  • Safety database, MedDRA coding and data entry experience.
  • Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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