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Job Details

Pharmacovigilance Specialist

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9639
Closing Date: 18 May 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Specialist. Lead support for the Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all products across Affiliate companies for which marketing authorizations are held. Provide leadership, training and support of junior staff.

Requirements:

Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Specialist.

Lead support for the Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all products across Affiliate companies for which marketing authorizations are held. Provide leadership, training and support of junior staff.

Responsibilities

  • Expectation of delegated tasks from QPPV on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
  • Review and advise relevant local and global guidelines, policies, Internal Procedures and SOPs across Affiliate companies
  • Case processing including triage, data entry, quality control and assessment of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources onto our global database, in accordance with company SOPs and regulatory requirements
  • Direct interaction with Regulatory authorities
  • Create and maintain contacts across all Affiliate companies to enable them to gain maximum benefit for the business from Scientific affairs
  • Need to keep abreast of changes and development in PV regulations.
  • Provide training and training material to new PV team members as required
  • Assessment and quality control of work completed by external providers (ADDS).
  • Managing the Safety Reporting Plans in line with the SDEAs.
  • Lead and manage projects including the development of project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
  • Develop project specific safety database customization and data entry guidelines
  • Participation in signal generation activities.
  • Triage of incoming reports for completeness, legibility and validity
  • Requesting follow-up i.e. written, telephone Adverse event (AE) and drug coding
  • Provision and quality control of line listings and tabulations for safety reports i.e. periodic safety reports, ad hoc safety reports etc.
  • Ensure project specific working files, case report files and project central files are created and maintained
  • Work with PVP and PVS as needed, with medical monitoring activities such as: drafting, writing and editing of SOPs/PSUR/PBER/PADAR
  • Safety database workflow management including case assignment and generation of Business Objects reports. Medical product dictionary (MPD) updates.
  • Preparation, review and submission of regulatory queries including the new QRD updates.
  • Reconciliation of ICSRs with distributors, affiliates and external providers to ensure compliance.
  • Delegate work to PVAs as required in the absence of PV team lead.
  • Quality assurance activities such as coordinator for audits and the development of templates checklists and guidelines.
  • Working closely with translation vendors to ensure quality translation of safety documentation.
  • Ensuring timely and appropriate responses to ad hoc requests and queries.
  • Attend training seminars as required in order to keep up to date with new PV regulations.

Safety:

  • Work with line management to ensure that adequate SOPs exist for all safety related Pharmacovigilance activities to be carried out in line with Good PV practices and according to worldwide Pharmacovigilance and EU regulations/requirements, to include activities by independent contractors and other third-party vendors where necessary
  • Data entry/review onto company safety database
  • MedDRA Coding
  • Review of safety information from clinical trials and post marketed products
  • Manage safety related requests or drug safety related information to ensure any requests are answered fully and promptly
  • Assess cases for seriousness and expectedness and identify SUSARs
  • Enter SAE information on to the safety database as per guidelines and run reports and queries as required
  • Fulfil regulatory reporting requirement for SUSAR reporting to the relevant Competent Authorities and Ethics Committees within stipulated timelines
  • Prioritising and managing individual workload to ensure regulatory and business partner timelines are adhered to for the reporting of SAE data
  • To review AE listings to identify data issues and safety trends as required.
  • To provide PV support to data management in reconciliation
  • To follow up any queries / issues raised as a result of reconciliation
  • Understanding and assisting with ADR reportability
  • Electronic/Paper Reporting of safety cases to regulatory agencies
  • Literature searching for ADRs
  • Writing sections of PSURs / DSURs
  • Coding of Adverse events
  • Producing summary safety tables / line listings for PV operations

Training/ Continuous Improvement

  • Improvise incentives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
  • Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature
  • Provide training and guidance and act as a mentor to less experienced departmental members.

Requirements

  • Life sciences/ Biological sciences graduate
  • Relevant pharmacovigilance work experience - approx 2 years
  • Competent with medical terminology
  • Excellent communication abilities and possessing good IT Skills
  • Results and performance driven – deliver results that meet or exceed expectations
  • Sense of urgency – responding to issues and opportunities in a timely manner
  • Intellectual curiosity – willing to suggest and try new ideas
  • Positive and pro-active approach to business tasks
  • Excellent interpersonal and communications skills.
  • A solutions provider with strong multi-tasking abilities
  • Manage evolving deadlines effectively with regular feedback and updates.
  • Enthusiasm and Drive to take ownership and drive process initiatives.

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

 

Apply for this job: Pharmacovigilance Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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