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Assoc. Dir./Director, Pharmacovigilance Safety Scientist

Cambridge, MA

Posted: 09/15/2020 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, PV and risk management activities. This is a leadership role within Global PVRM to actively evaluate and manage risk in collaboration with PV Physicians and Medical Monitors. This individual will be primarily responsible for reviewing of ICSRs, authoring and reviewing aggregate safety reports such as DSURs/ IND annual reports, safety signal detection and management activities and periodic literature monitoring of investigational products. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. 

How you will spend your day:
  • Providing PVRM expertise for our Client’ s Clinical Development program including Clinical, Investigator Sponsored and Compassionate Use Programs; liaise with Clinical Development, Clinical Sciences, Clinical Operations, Biostatistics, Regulatory Affairs, Medical Writing, Quality, CROs, DSMBs and other entities as needed to contribute to overall study execution while ensuring safety strategy and operational excellence.
  • Preparing and reviewing of safety-related section(s) for clinical, regulatory, and scientific documents.
  • Leading and/ or contributing to the creation and maintenance of Reference Safety Information.
  • Performing review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting.
  • Leading and/or participating in signal detection activities and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.
  • Leading author and/or contributor to the preparation of aggregate safety reports and ensure consistent communication of safety topics across various regulatory safety documents.
  • Providing guidance with adverse event (MedDRA) and drug (WHO-Drug) coding.
  • Assisting in the support and oversight of pharmacovigilance service vendors.
  • Developing or contributing to development of PVRM department processes.
  • Demonstrating knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.
  • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.

Key things about you:
  • Bachelor’ s level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
  • At least 5-7 years of drug safety and risk management experience within the pharmaceutical, biotech or CRO industry.
  • 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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