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| Job Field | Discipline | Region | Actions |
| Regulatory And Drug Safety | Drug Safety | Bedfordshire, Buckinghamshire, Hertfordshire, London,... | Details |
| Job Summary:
Regulatory Affairs role within mid sized Pharma Company in Hertfordshire. Summary - Maintain marketing authorisations for both the UK and Ireland to meet regulatory requirements. Provide a medical information service and monitoring/reporting of Pharmacovigilance cases to meet regulatory and legislative requirements. Ensure compliance to company policies and procedures with respect... [Full Details] |
| Salary: Negotiable (25000 - 30000 £) |
| Regulatory And Drug Safety | Drug Safety | Any Location (Switzerland) | Details |
| 1. Develops with PVLs/BSLs AE assessment and coding conventions for oncology pro-jects/products and prepares event specific questionnaires
2. Assists with ad hoc literature searches through initiation of process and screening reports and preparation of summary to be reviewed by PVL or BSL.
3. Facilitates reconciliation with clinical trial data in close collaboration with PVO and ensures... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Any Location (Luxembourg) | Details |
| Our client, a leading European pharmaceutical company is looking to recruit a:
Junior Pharmacovigilance Officer (m/f)
for their Head Office in Luxembourg.
Major responsibilities:
Agreements / Archive.
- Develop and maintain an effective Pharmacovigilance archiving process and ensure that all data is kept in an inspection and audit ready state at all times
- Assist in the drafting and... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Any Location (Germany) | Details |
| Working within a global Pharmacovigilance team for a large Pharmaceutical company, you will be responsible for:-
Sue of adverse event reports from clinical studies and reports from the licensees of operational units in the European Region
Coding of adverse event reports with medical dictionaries MedDRA, WHO Drug Dictionary
Active tracking of discrepancies in the context of Adverse event... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | London (United Kingdom) | Details |
| Senior Drug Safety Associate
Based in London
Permanent/Full Time
Salary - c£40,000 + benefits
This is an excellent opportunity to join an established CRO and work as Senior Drug Safety Associate
Job Requirements
•Lead and manage projects including the development of project specific safety reporting procedures and workflow and provide guidance to the team on the... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Wilmington
Description
The basic purpose and objective of this position is to provide safety support to the Safety and Medical Management Division, which includes safety database entry, Access and Excel database entry, scanning, quality control of scanned documents, report distribution internally... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Wilmington
Description
The basic purpose and objective of this position is to provide safety support to the Safety and Medical Management Division, which includes safety database entry, Access and Excel database entry, scanning, quality control of scanned documents, report distribution internally... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Wilmington
Description
The basic purpose and objective of this position is to provide safety support to the Safety and Medical Management Division, which includes safety database entry, Access and Excel database entry, scanning, quality control of scanned documents, report distribution internally... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Berkshire, Buckinghamshire, Hampshire, London, Surrey,... | Details |
| Job summary
• Top 10 Pharmaceutical company
• Long term rolling contract
• Permanently employed by Chiltern
• Office based in Surrey
Job Background
The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Surveillance Associate / Scientist to work for our client,... [Full Details] |
| Salary: Negotiable (28000 - 34000 £) |
| Regulatory And Drug Safety | Drug Safety | Bedfordshire, Berkshire, Buckinghamshire, Hampshire,... | Details |
| Pharmacovigilance Coordinator
Berkshire
12 month fixed term contract
Competitive Salary, Plus Benefits
This is a 12 month fixed term contract working as a Pharmacovigilance Coordinator based in Berkshire, this is an excellent position to develop a career within pharmacovigilance.
Key Responsibilities
•Centralizing Serious Adverse Event Reports
•Working with deadlines for... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Dublin (Ireland) | Details |
| Our client is a leading global biopharmaceutical company. They are currently seeking a full time Senior QA Specialist (GMP) within their Supplies/Manufacturing division to be based on site in Dublin, Ireland.
JOB ROLE:
To ensure that all appropriate batch related documents and finished product packs are available from the contractors/suppliers to enable the release of products for sale or... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Any Location (United Kingdom) | Details |
| Our very respectable client based in central London is looking for a PVG Scientist to join their team on a permanent basis.
PURPOSE OF ROLE
To process Serious Adverse Event Reports (SAEs) from Clinical Trials
•To identify SUSARs and fulfil regulatory reporting requirements for SUSAR reporting to the relevant Competent Authorities and Ethics Committees
•To contribute to and author... [Full Details] |
| Salary: Negotiable (30000 - 37000 £) |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Wilmington
Description
The Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated HCP, tracking of reports, and regulatory reporting activities. The Safety Specialist... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Wilmington
Description
The Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated HCP, tracking of reports, and regulatory reporting activities. The Safety Specialist... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Hertfordshire (United Kingdom) | Details |
| PRINCIPAL RESPONSIBILITIES :
• Perform Quality Compliance review/release of Investigational Medicinal Products for use in Clinical Trials
• Audit and approve procedures and documents from manufacturing, analytical and service groups
• Assist with ensuring compliance to cGMP of all activities related to the development of pharmaceutical products for use in Clinical Trials, including... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Buckinghamshire (United Kingdom) | Details |
| JOB ROLE:
The Principal Medical Writer will assist with the authoring of regulatory documents for clinical research, including clinical study reports, clinical summary sections of common technical documents, investigator brochures, protocols, and other clinical documents.
PRINCIPAL RESPONSIBILITIES include:
• Compiles and assembles components of clinical documents in accordance with... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Any Location (Switzerland) | Details |
| Local Safety Specialist- Switzerland
Description:
A Swiss subsidiary of a leading internationally Pharma company are looking for a motivated person to take up the position of Local Safety Specialist.
The Local Safety Officer is responsible for pharmacovigilance but additionally responsible for quality assurance, complaint handling and preparation of SOPs; training responsibilities and... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Buckinghamshire, Cambridgeshire, Hertfordshire (United... | Details |
| Senior Drug Safety Associate
Cambridgeshire
Permanent Full Time
Excellent Salary and Benefits
A pharmaceutical company are seeking a permanent Senior Drug Safety Associate to join the team. This is an excellent opportunity for a candidate seeking to broaden their safety knowledge and to be part of a progressive department.
Job Description
•Case processing of clinical and post... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | London (United Kingdom) | Details |
| JOB ROLE:
The Document & Submissions Coordinator will support the Regulatory Operations Team in the creation of regulatory submissions and in the delivery of regulatory submission components and product dossiers.
PRINCIPAL RESPONSIBILITIES include:
• Formatting & troubleshooting source documents
• Document management and conformance to assigned templates
• Quality Control checks... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Kent (United Kingdom) | Details |
| PRINCIPAL RESPONSIBILITIES include:
• To manage projects and product-related registration strategies in the assigned countries whilst being the single point of contact for the Country Office team
• To ensure that regulatory documentation meets relevant regulatory requirements for the region
• To apply knowledge and interpretation of regulatory requirements in the assigned countries... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | London (United Kingdom) | Details |
| JOB ROLE:
The Associate Director’s role is to plan/manage/execute regulatory activities relating in EU territories on assigned oncology project or projects (either investigational or marketed products).
The successful candidate will also develop innovative regulatory strategies for product development and approval for assigned oncology products (small molecule and biologics), prepare or... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Morrisville - 1800 Perimeter
Description
The Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated HCP, tracking of reports, and regulatory reporting activities. The... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Morrisville - 1800 Perimeter
Description
The Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated HCP, tracking of reports, and regulatory reporting activities. The... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | North Carolina (United States Of America) | Details |
| Job Category Pharmacovigilance
Primary Location North America-United States-North Carolina-Morrisville - McCrimmon
Description
The Safety Specialist, working alongside a more experienced member of staff, will coordinate serious adverse event (SAE) processes and database activities, and develop an understanding of budgets and forecasts for assigned projects. He/she must be familiar with... [Full Details] |
| Salary: Negotiable |
| Regulatory And Drug Safety | Drug Safety | Any Location (Switzerland) | Details |
| Our global client in Switzerland is looking for a Head IMS Operations to join their expanding department on a permanent basis.
Leads the liaison with Global Drug Safety&Epidemiology (DS&E), as well as the different line functions within Oncology Global Development, to drive process improvement and quality assurance related to drug safety aspects globally.
Leads the continuous improvement,... [Full Details] |
| Salary: 100000 - 130000 £ |
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