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Sr. Scientist, Global Pharmacovigilance & Risk Management

Cambridge, MA

Posted: 08/06/2020 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2505

Job Description

This position is responsible for global safety assessment of investigational products throughout their lifecycle. This includes all pre-marketing safety, Pharmacovigilance and risk management (PVRM) activities. This individual will work together with the Sr. Director in managing the safety assessment of products, including review of individual and aggregate AEs and preparing safety reports. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

  • Provide PVRM expertise for our client’ s Clinical Development program including Clinical, Investigator Sponsored and Compassionate Use Programs; liaise with Clinical Sciences, Clinical Operations, Biostatistics, Regulatory Affairs, CROs, DSMBs and other entities as needed to contribute to overall study execution while ensuring safety strategy and operational excellence.
  • Prepare and review of safety-related section(s) for clinical, regulatory, and scientific documents.
  • Lead and/ or contribute to the creation and maintenance of Reference Safety Information.
  • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting.
  • Lead and/or participate in signal detection activities and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.
  • Lead author and/or contribute to the preparation of aggregate safety reports and ensure consistent communication of safety topics across various regulatory safety documents.
  • Provide guidance with adverse event (MedDRA) and drug (WHO-Drug) coding.
  • Assist in the support and oversight of pharmacovigilance service vendors.
  • Develop or contribute to development of PVRM department processes.
  • Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), company SOPs and quality standards.
  • Keep abreast of new PV/safety regulations and guidance from the regulatory authorities.

Requirements / Qualifications:
  • Bachelor’ s level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
  • 3-5 years global clinical PVRM experience; some safety science experience preferred.
  • Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP).
  • Ability to manage multiple tasks with deadlines in fast-paced working environment.
  • Flexible to operate comfortably in a rapidly changing and sometimes ambiguous environment.
  • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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