PV Scientist (Sr Manager, AD level)

  • Gardner, MA

Employment Type

: Full-Time

Industry

: Non-Executive Management



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Job Summary

Beacon Hill Pharma is currently hiring a Sr Manager/Associate Director, PV Scientist for a direct opportunity in the Greater Boston area .


Responsibilities:


The Sr Manager/Associate Director, Pharmacovigilance Scientist supports the medical component of pharmacovigilance activities including: surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for Client's products. They collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks.



  • Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety Management Team meeting; ensure adequate documentation of meeting minutes

  • Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection

  • Support other function teams for investigational products; serve as PV expert and liaise with Clinical Operations, Biostatistics, Regulatory Affairs, Contract Research and other entities as needed

  • Provide oversight for the safety data analysis and manage PV Scientists

  • Evaluate medical coding of safety data

  • Contribute to health authority and other safety related query responses

  • Support study teams for investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs,

  • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)

  • Ensure compliance with and PVG & Risk Management policies and procedures

  • Prepares aggregate safety reports (e.g. DSURs, PSURs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks

  • Plans and executes literature surveillance

  • Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports

  • Support PV activities as needed


  • Qualifications



  • PharmD, MD, PhD, MPH, advance healthcare degree, or equivalent professional experience

  • Minimum 8 years' pharmacovigilance or relevant experience, including at least 5 years' concentration on aggregate safety report writing

  • Thorough understanding of the drug development process and context applicable to safety surveillance activities

  • Knowledge of MedDRA terminology and its application

  • Excellent written and oral communication skills, strong attention to detail, and high performance standards for quality

  • Ability to analyze, interpret, and summarize complex clinical and medical literature data

  • Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality

  • Displays ability to understand established procedures and communicate those procedures to others

  • Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance

  • Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas

  • Possesses computer skills to support use of electronic systems and development of writing deliverables



  • Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.



    Associated topics: clinical, diet, dietetic, healthcare, immuno oncology, industrial hygienist, metabolism, microbiology, nutrition, protein


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