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Job Details

PV Associate - Pharma/London

Company: Planet Pharma Staffing Limited
Location: Middlesex, London
Reference: SCPV18
Closing Date: 01 Sep 17
Type: Contract
Salary (£): 30,000 - 40,000
Benefits: NA

Job Summary:

My client is a hugely successful biopharma and one of the most promising companies in industry right now. With major blockbuster Oncology products set to hit the market in the next few months this is a hugely exciting time to be part of their innovations! Please get in touch immediately if interested at advancing your career!

Requirements:

PV Associate / Drug Safety Associate / DSA

PURPOSE

To manage safety data within Client’s central safety database covering both pre and post market activities. To ensure compliance with internal case processing timelines. A regional role based in the UK.

KEY RESPONSIBILITIES

Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised and translation of source documents as needed

AE CASE MANAGEMENT

  • Data Entry and Assessment
  •  Conduct full data entry from source document
  • Execute QC on key fields of serious cases and update ARISg as needed
  • Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
  • Identify SUSARs from blinded clinical studies and alert Drug Safety Management to the need for unblinding
  • Create narrative as defined by conventions
  • Create draft company comments for serious cases
  • Rank events and determine challenge/rechallenge information
  • Develop follow-up needs for AE reports and create follow-up letters, review and update generated follow-up letters as appropriate
  • Update communication log in ARISg as needed
  • Authorise (approve) non-serious cases
  • Notify Workflow/Drug Safety Manager if any delay in case processing is observed
  • Review and resolve ARISg validation errors

Medical Review

  • Support the identification of corrections and creation of updates in ARISg following medical review
  • Discuss issues with medical reviewers as appropriate

Internal Global Safety Development

  • Contribute to conventions and process documentation as required
  • Support continuous improvement of processes and safety database
  • SAE and PM non serious AE investigation needs

 Outputs

  • Adverse Event case report data within the central safety database
  • Case narratives for incorporation within company documents
  • Accurate and timely case safety reports for submission to regulatory agencies

Decision Making Authority

  • Data fields for full data entry
  • Assessment of cases & initial coding of all events
  • Final content and approval of individual Non-SAE reports

Skills/Knowledge Required:

Experience      

•          Two (2) years relevant clinical experience or relevant scientific background equivalency

•          Two (2) years relevant experience in the Industry

•          Data entry/data management or document management experience

Knowledge

  • Clinical knowledge of therapeutic area patient populations and drug class
  • Computer and database skills preferred
  • Medical terminology
  • Applicable Pharmacovigilance legislation

Competencies

  • Organisation and planning
  • Team work
  • Attention to detail
  • Data management
  • Time management
  • Flexibility

Duration

12months +

Compensation

Attractive hourly rate 

Location

Office based In Middlesex

About Planet Pharma

Planet Pharma was founded by a dedicated team of seasoned professionals with extensive experience supporting the pharmaceutical, biotechnology and device industries. We are a unique staffing agency that have dedicated recruiters solely focussing on candidates to support the clients we work with.

Innovative – We constantly explore new ways of working that will help us be more efficient and effective

Entrepreneurial – We look at things differently, immerse ourselves in your world and devise solutions for each and every client

Expert – Everyone on our team is an expert in their field, trained and continually learning to deliver an unrivalled level of experience

Passionate – We are all incredibly proud to be part of Planet Pharma and we genuinely care about the people we work with

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

To Apply

All successful applications will be responded to within 24 hours, if you do not hear back in 7 days please assume you have been unsuccessful. For more information on job roles please contact Sam Chapple at Planet Pharma:

Tel: +44 203 868 8607

Email: schapple@planet-pharma.co.uk

Keywords

PV, Pharmacovigilance, drug safety, case processing, susar, Adverse events, literature writing, pharmaceutical, CRO, London, Middlesex, Surrey, Hertfordshire, Buckinghamshire

Apply for this job: PV Associate - Pharma/London

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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