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Senior Manager, Safety Submissions job in Edinburgh at CLINIPACE

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Senior Manager, Safety Submissions at CLINIPACE

Senior Manager, Safety Submissions

CLINIPACE Edinburgh, City of Edinburgh Full Time

Job Overview:

The Senior Manager, Safety Submissions leads the efficient and compliant pharmacovigilance (PV) operational processes associated with safety submissions performed by the Company’s Pharmacovigilance department. The Senior Manager performs the required activities listed below with minimal supervision, in accordance with all applicable regulatory requirements, Good Clinical Practices (GCP)/International Conference on Harmonization (ICH) guidelines, Standard Operating Procedures (SOPs), and project-specific requirements, as applicable. Issues will be escalated as required. The Senior Manager builds and manages internal and business relationships while serving as liaison between the Sponsor/client, project team, and other departments.

Job Roles and Responsibilities:


  • Understands pharmacovigilance processes and requirements to operate in accordance with established safety processes, including but not limited to:
  • Generating regulatory report forms, as applicable (e.g. CIOMS I, MedWatch, country-specific forms and/or XML)
  • Expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs), Unanticipated Adverse Device Effects (UADEs) and other expedited reports
  • Periodic reporting [e.g. line listings, Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs)]
  • Accurate and timely tracking of safety submissions
  • Pharmacovigilance/Trial Master File filing
  • Oversees the collection and maintenance of regulatory intelligence for safety reporting requirements in all regions where Pharmacovigilance is contracted to perform submissions
  • Oversees the workload management of relevant projects and assigns staff to new projects
  • Oversees new project set-up, including preparation of the Safety Management Plan
  • Identifies when updates are needed to Safety Management Plans
  • Contributes to the identification of quality events with root cause assessment and development of appropriate corrective and preventive actions
  • In-depth knowledge of EudraVigilance to advise clients with company registration and act as responsible person (RP) for EudraVigilance
  • Knowledge of safety reporting processes to US FDA and Health Canada
  • Project Management

  • Manages the timely delivery of contracted safety services in compliance with the approved contract, budget, and transfer of obligations
  • Participates in management of safety vendors, as necessary, including vendor for site letter distribution
  • Oversees invoicing and identification of when change orders are required for designated projects
  • May serve as Pharmacovigilance Project Manager for stand-alone Functional Service Provider (FSP) projects and/or other projects involving only safety submissions for PV
  • Contributes to audit planning and readiness activities for safety services
  • Supports with development and maintenance of submissions tracking system
  • Communication

  • Works effectively with internal/external colleagues and has the ability to lead cross-functional teams to address complex issues and recommend actions with potentially significant impact
  • May represent PV in project handover, internal and/or external kick-off meetings, and audits
  • May meet with clients to discuss safety reporting requirements
  • Sales Support

  • Supports Pharmacovigilance service line growth by ensuring consistent and comprehensive safety risk management and regulatory compliance execution
  • Participates in bid defense meetings, provides input for RFP and RFI responses, and reviews safety budgets, as requested
  • Process Management and Improvement

  • Works to enhance a solid safety program by introducing greater process optimization, operational efficiency, and risk analysis techniques.
  • Understands the organization, PV and fit within it, including key interfaces with other departments; able to work effectively to accomplish objectives
  • Continuous improvement: continually reviews internal and client-interfacing processes and performance to identify opportunities for improvement and efficiency gains; generates creative solutions to business challenges and fosters innovation
  • Intermediate analytical thinking: diagnoses complex situations with broad impact and exercises sound judgment in recommending solutions
  • Works through conflicts and drives productive resolution
  • Strategic thinking: analyzes opportunities and issues from a broad, long-term perspective
  • Participates in the development and maintenance of SOPs / work practices related to Pharmacovigilance
  • Ensures the collection of project metrics within the team
  • Solicits user feedback for technology platform improvements and applications; liaises with Information Technology, as appropriate
  • Supervisory Responsibilities:

    Manages and supervises Pharmacovigilance staff and carries out supervisory responsibilities in accordance with the Company’s policies, including but not limited to: Resource planning, recruiting, and performance management; Training and development; and Work prioritization, resource allocation and delegation.

    Job Requirements:

  • Education Bachelor’s degree in a science or healthcare related field (nursing, pharmacy, life sciences or medicine required) Advanced degree (Masters or doctorate, e.g., PharmD or PhD) helpful.
  • Experience Minimum of 6 years of experience within the Pharmaceutical/CRO industry, or equivalent experience in a clinical setting Minimum of 3-5 years of experience in Pharmacovigilance or equivalent clinical experience Minimum of 2 years of management experience
  • Skills/Competencies At least a basic understanding of medical terminology, clinical drug development, and regulatory classifications of drugs/biologics/devices/investigational and marketed products In-depth knowledge of regional pharmacovigilance/safety regulations; high level knowledge of global pharmacovigilance/safety regulations; experience in how to obtain updated regulatory intelligence information Ability to drive and champion changes with broad impacts; understands and responds to the needs of various stakeholders Ability to clearly and persuasively describe ideas/perspectives and to solicit required commitment and participation of stakeholders Advanced written and verbal communication skills sufficient to convey ideas clearly to multiple audiences in English Ability to use advanced features of basic system applications and to identify ways to address new needs using a combination of process and technology Ability to adapt within an environment of rapidly changing priorities and workload Strong initiative, strong organizational and time management skills Ability to lead, plan and manage change Ability to set priorities and lead pharmacovigilance initiatives including staffing Ability to maintain client and corporate confidentiality Ability to make sound decisions relating to the advancement of the company mission and goals Ability to effectively interact with external clients and community and represent the company and company values and mission Strong written, verbal and negotiation skills Excellent analytical, problem solving, communication and interpersonal skills Previous experience managing and developing staff Ability to lead and participate in a cross-functional team environment Strong computer skills, including Microsoft Office products Comprehensive knowledge of GCP/ICH guidelines Expert proficiency in medical terminology Ability to exercise judgment within defined procedures and practices and to determine appropriate action independently Exceptional attention to detail Superior problem-solving skills
  • Capabilities Must have a credit card that can be used for travel expenses Ability to work remotely Up to 5% travel, as needed.

    Recommended Skills

    • Ich Guidelines
    • Interpersonal Skills
    • Pharmacovigilance
    • Strategic Thinking
    • Good Clinical Practices (Gcp)
    • Trial Master File
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    Job ID: 0462ddbcbad7