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Drug Dafety Specialist 1868

  • Job reference: 931145
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 16/06/2020

Orion Group are recruiting for a Drug Safety Specialist on behalf of our Multinational Pharmaceutical Client on an initial 12 month contract based in the Buckinghamshire Area

  • Collects and records data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products.
  • Reviews and determines regulatory reporting requirements based on assessment of seriousness, causality and expectedness/listedness in accordance with regulatory guidelines and product labelling.
  • Assigns codes to adverse events for input into appropriate database.
  • Establishes adverse event files and tracking systems.
  • Prepares adverse event reports for submission to regulatory agencies within the appropriate reporting timeframes.
  • Verifies accuracy, completeness and validity of information for each report.
  • Interacts with health professionals and consumers to obtain and follow up on reports of possible adverse events.
  • Reviews cumulative safety data for submission to regulatory agencies.
  • Classifies, tracks and documents potential adverse events which do not meet criteria for entry into database.

Principal Responsibilities:

  • Triage of incoming cases to prioritize for daily workflow management
  • Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
  • Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
  • Preparation of SUA summary: Analysis of Similar Events
  • Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
  • Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
  • Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
  • Completion of all assigned training on company and GMSO procedural documents relating to case processing
  • Completion of training relating to relevant PV Agreements for assigned products
  • Participate in designated activities to support revision/creation of case processing procedural documents

Desired Experience:

  • Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
  • Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
  • Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years' experience in pharmaceutical safety-related role
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
  • Understanding of medical terminology and ability to summarize medical information
  • Ability to follow guidelines and procedural documents (experience of working with SOPs etc. preferred)
  • Oriented to quality, attention to detail and accuracy
  • Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines

#Pharmaceutical #multinational #product #drugsafety #CAPA #PV #pharmacovigilance

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 / +353 86 0327943 or email Denise.Cagney@orioneng.com for a completely confidential chat about this role.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.