Associate Director, Pharmacovigilance (PV) Operations

Company: Precision Medicine Group
Location: Gladstone
Posted on: November 1, 2024

Job Description:

Associate Director, Pharmacovigilance (PV) Operations
at Precision Medicine Group (View all jobs)
Remote, United States

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as an Associate Director, Pharmacovigilance (PV) Operations?

Position Summary:

The Associate Director, Pharmacovigilance (PV) Operations will be responsible for setting up and managing the Drug Safety and Pharmacovigilance Group's operational systems and processes to improve efficiency and effectiveness. This role includes creating a corporate training program for pharmacovigilance and overseeing safety studies to ensure compliance and consistent performance. Additionally, the Associate Director will handle performance metrics, quality control of safety cases, and ensure that SAE and SUSAR reporting for clinical trials meet global compliance standards.

Essential functions of the job include but are not limited to:

• Responsible for the day-to-day management and execution of Drug Safety/PV operations
• Responsible for oversight of all aspects of case processing including but not limited to triage, data entry, narrative writing, medical review, follow-up, AOSEs, SUSAR reporting, and query resolution.
• Oversee day to day activities related to case processing workflow, safety mailbox, and reconciliation.
• Oversee daily interactions with Sponsors, vendors, tracking case progress and adherence to timelines.
• Provide technical and case management support to ensure accurate and complete information in the safety database.
• Ensure global clinical trial case reporting is efficient and meets safety management plan requirements.
• Contribute to aggregate report review and approval.
• Develop and maintain pharmacovigilance SOPs and training, and lead quality management and compliance plans.
• Track compliance metrics and assist with corrective action plans from audits and inspections.
• Prepare and/or review of safety training materials and manage, train and mentor staff, consultants, and/or contractors.
• Responsible for coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development.
• Assist with the planning, coordination, and management of internal and external safety resources to accomplish assignments to the highest quality standards within the given deadlines.
• Participate in regulatory inspections and sponsor/company audits and prepare response to audit findings concerning the Drug Safety department.
• Must be able to travel as needed/required
• Support Precision leadership in strategic planning and other duties as assigned.
  Education and Skills Required:
  
  • Bachelor's degree or higher in Health/Biomedical Sciences related field or other equivalent educational training
  • Minimum of 8-10 years of global Drug Safety / Pharmacovigilance experience in pharmaceutical/biotech industry and/or CRO.
  • Minimum 5 years managing people
  • In-depth knowledge of FDA, EU, and ICH guidelines for clinical trials and post-marketing safety.
  • Proven experience managing pharmacovigilance vendors.
  • Strong understanding of medical terminology and adverse event assessment principles.
  • Proficient in using MedDRA dictionary and drug safety systems (e.g., ARISg, ARGUS, Medidata Rave).
  • Excellent communication skills, with the ability to work effectively across functions and cultures.
  • Demonstrated ability to think critically, build relationships, and lead or contribute in a team setting, with a commitment to company values and mission.
    Other Required:
    
    • Experience with case processing in ARGUS
    • Demonstrated ability to challenge existing practices to become more effective.
    • Ability to effectively adapt to a variety of situations.
    • Meet quality and performance standards.
    • Strong influencing skills
    • Excellent communication skills, both written and oral
    • Work effectively as a team member and promotes collaboration.
    • Demonstrate ownership, initiative and accountability.
    • Supervisory experience
      Competencies:
      
      • Ability to deliver on commitments and understanding of service culture.
      • Communicates effectively and efficiently on safety issues to internal and external stakeholders.
      • Maintain consistency of safety assessments.
      • Serve in cross-functional teams as Drug Safety expert.
      • Monitor regulatory compliance of safety reporting throughout trial.
      • Lead and contribute to process development and/or process improvements that support Drug Safety
        Preferred:
        
        • Health care professional (RN, Pharm.D., MD, or equivalent) is preferred.
        • Clinical Trial experience preferred.
          
          #LI-Remote
          
          Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
          
          Reasonable estimate of the current range
          
          $125,200 - $187,800 USD
          
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          Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. - 2020 Precision Medicine Group, LLC
          
          If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .
          
          It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Keywords: Precision Medicine Group, New Haven , Associate Director, Pharmacovigilance (PV) Operations, Executive , Gladstone, Connecticut