- Beacon Hill Staffing Group, LLC
237 Green St
Beacon Hill Pharma is currently hiring a Sr Manager/Associate Director, PV Scientist for a direct opportunity in the Greater Boston area .
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: biomedical, cytometry, drug development, histotechnologist, medicine, microbiology, nephrology, nutrition, pharmacology, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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