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PV Consultant, Case Management

Orkney Isles   •  £35 - £55 per hour  •  Contract/Temporary, Full time

My client is currently searching for a case management specialist to join their team on a full time 12 month contract basis.  Within this role you will be responsible for participating in and enabling the timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and the clients standard operating procedures and guidelines.

Key Intake & Submissions Team activities may include, but are not limited to:

  • Timely intake, reconciliation and submission of Individual Case Safety Reports (ICSRs) to and from destinations including but not limited to global regulatory authorities, business partners, investigators, and ethics committees in compliance with applicable global regulations/reporting requirements and standard operating procedures and guidelines. In addition, may contribute to the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other business area needs related to AE Intake or reporting.
  • Regulatory Intelligence Review for ICSR Intake & Submission Requirements, and reference tracking tool maintenance
  • Authoring and maintaining AE Intake and ICSR Submissions processes and standards, including AE follow-up
  • Act as an expert resource for AE Intake and ICSR Reporting Requirements and system configuration requests associated with, but not limited to:
  • Med Affairs/Commercial programs, Product Launches, RWE & Mkt Research programs, Product Withdrawal or license transfer, Social Media, Business Partner case exchange etc.
  • Perform or oversee Serious ICSR Finalizations & Submissions
  • Input to ICSR exchange timelines in Business Partner SDEAs, maintain reference tracking tool, and initiate requests to SSM for configuration/update of associated system rules for Business Partner SDEAs
  • ICSR Reconciliations from all sources other than Clinical
  • Ensure proactive quality of delivery by PV Service providers and internal staff for AE Intake & Submission activities
  • Operational vendor oversight ? AE intake vendor(s)

Essential Functions:

  • Adheres to company templates and GxP guidelines for documentation and communications
  • Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training
  • Other duties as required to support case management operations and teams
  • Participate in the development and maintenance of adverse event case management workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
  • May assist in coordinating the department?s workflow and assist with special projects under the direction of the CM department management.
  • May serve as an individual contributor or a project manager for functional projects or workflows.
  • May mentor other CM team members, including service providers
  • Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating
  • Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines.
  • Work collaboratively with the PVAM, R&D Quality, PV Quality & PV Compliance teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes

Required Knowledge, Skills, and Abilities:

  • 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience.
  • Experience of case entry
  • Knowledge of FDA and international regulations pertaining to Adverse Event and ICSR requirements, as well as ICH guidelines, including the ability to interpret and apply applicable regulations to inform decisions and resolve issues
  • Proficiency in standard desktop software programs (Word, Excel, Outlook)
  • Experience using MedDRA and MedDRA coding
  • Understanding of medical terminology and ability to summarize medical information
  • Excellent oral and written communication skills
  • Highly organized and demonstrates consistent attention to detail
  • Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  • Flexibility to work outside of normal working hours or on-call arrangements

Required/Preferred Education and Licenses:

  • BS/BA degree in health related or biological science related field

Fort further details, please contact Tim Barratt on 01727 817 626 or email a copy of your CV to tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: BH-33319
  • Posted: 9th June 2022
  • Expires: 7th July 2022

Achieva Group Limited

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