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Job Details

Drug Safety Specialist

Company: Planet Pharma Staffing Limited
Location:
Reference: 45160
Closing Date: 28 Feb 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Our client is a global integrated biopharmaceutical company currently seeking a Drug Safety Specialist to joint their team. You will be responsible for managing safety data for both pre and post marketing activities while ensuring compliance with internal timelines. This is a full-time, 1 year contract position based in Stockley Park, UK.

Requirements:

Company Statement

Our client is a global integrated biopharmaceutical company with offices across 60 countries. They focus on the discovery, development and commercialization of innovative therapies where there are limited options for patients and provide expertise in the areas of oncology, immunology and hematology. They have been awarded as one of the fastest growing pharmaceutical companies as a result of their entrepreneurial spirit, cutting-edge technology and company values, such as a teamwork-oriented culture and passion for patient’s wellbeing.

Role/ Description

Responsibilities:

  • Responsible for ensuring that adverse event case reports are properly investigated and evaluated against regulatory requirements
  • Make decision and document them regarding ICSRs
  • Responsible for tracking electronic safety submissions and addressing any technical issues
  • Responsible for Adverse Event Case management by performing data entry intro ARISg, making follow up calls and escalate reports internally within drug safety
  • Execute case assessment, including review coding and events, create narrative and comments for serious cases.
  • Identify SUSARs from blinded clinical studies and identify need for unblinding
  • Resolve any validation errors within ARISg
  • Perform medical review activities
  • Support improvement of processes and safety database

Requirements:

  • At least 2 years of experience in a clinical setting
  • Experience with data entry and management
  • Knowledge of medical terminology, therapeutic area, patient populations and drug class
  • Experience working with MedDRA and WHODRUG
  • Knowledge of global regulatory requirements for pharmacovigilance regarding clinical trial and post-marketing activities, including FDA, EMA and ICH guidelines
  • Strong attention to detail, time management, organization and communication skills

 

About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

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.

www.planet-pharma.com

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3868 1000 or e-mail on EURecruiters@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Keywords 

Drug safety, ARISg, adverse events, safety database, compliance, ICH

Apply for this job: Drug Safety Specialist

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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