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Job Details

MANAGER, CLINICAL SAFETY REPORTING - HOME BASED UK/EU

Company: Novella Clinical Resourcing
Location: Home based UK/EU
Reference: NC-SafRepMan
Closing Date: 24 Feb 18
Type: Permanent
Salary (£): On Application
Benefits: Industry benchmarked benefits

Job Summary:

Novella Clinical, a Quintiles company, are seeking a Clinical Safety Reporting Manager to work home based in the UK/EU. Candidates must have hands on experience of Eudravigilance submissions and good knowledge of xEVMPD registration as well as prior line management experience . This role is permanent and full time.

Requirements:

Novella Clinical, a Quintiles company, has a vacancy for a Manager, Clinical Safety Reporting. This role is permanent, full time and can be home based in the UK or EU.

The purpose of this role is to oversee and manage global clinical safety reporting activities within Novella Global Safety Management including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MDs) according to applicable regulatory requirements. Prior MD&D experience would be useful but not essential.

The successful candidate will perform and oversee research and assessment of safety related regulatory intelligence globally, coordinate and oversee submissions by assigned staff and ensure compliance with applicable regulations and internal metrics.

The Manager, Safety Reporting, will not only have the ability to manage staff but will also be able to provide expert advice and project oversight for safety reporting only projects.

They must also be able to support Eudravigilance ‘RP’ services and client xEVMPD registration.

CANDIDATES MUST HAVE DRUG SAFETY REPORTING EXPERIENCE AND BE BASED IN THE UK OR EUROPE. THIS IS NOT A H&S ROLE.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Maintains/acquires in depth knowledge of global safety regulations as applicable to Novella business
  • Oversees and trains safety staff on applicable safety related regulations
  • Serves as safety reporting resource for project teams, management and clients as requested
  • Develops and maintains applicable controlled documents (i.e.  SOPs, WPs)
  • Develops and maintains templates for project specific documentation (i.e. Safety Reporting Plan) and provides support for implementation if needed
  • Supports project teams in regards to safety reporting process setup and maintenance
  • Reviews, approves or provides input into global safety reports, as necessary
  • Cooperates with other departments and functions as required to support on-time submissions
  • Contributes to development and implementation of KPIs related to safety reporting
  • Contributes to development and implementation of metrics related to reporting compliance and productivity
  • Supports development of budgets and proposals as required
  • Supports other business development activities as assigned by supervisor or designee

 

KNOWLEDGE, SKILLS AND ABILITIES:

  • Full ability to understand the significance of timelines and willingness to make all efforts to meet deliverables
  • Ability to work independently, prioritize effectively and work in a matrix team environment
  • Professional level knowledge of GCP/ICH guidelines for conducting clinical research.
  • Knowledge of Medical Device regulations, both pre- and post-marketing would be beneficial but not essential.
  • Very good knowledge of electronic safety databases (preferably including Argus)
  • Good knowledge of electronic safety reporting systems (e.g. EudraVigilance, safety database gateway)
  • Solid quality assurance skills, e.g. for development and maintenance  of compliance metrics, management of CA/PAs
  • Ability to form strong working relationships across functional areas
  • Ability to motivate, manage and grow assigned team members
  • Excellent written and verbal communication skills required
  • Excellent computer literacy including experience of working with Microsoft Office PowerPoint, Visio desired

 

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor's Degree in a relevant medical / scientific area (i.e. nursing, pharmacy, pre-medicine, clinical research etc.) or equivalent (e.g. experienced healthcare professional.)
  • At least 7 years of overall Safety / Pharmacovigilance experience with an emphasis on regulatory safety reporting
  • Appropriate clinical research experience including electronic data management systems, EDC, safety database usage
  • Professional knowledge of issues affecting Safety / Pharmacovigilance reporting for clinical trials of IMPs and medical devices
  • Documented continuing education in Safety / Pharmacovigilance with an emphasis on global safety reporting for drugs and medical devices.
  • Prior experience with EudraVigilance submissions required
  • Prior experience with use of regulatory databases (i.e. Cortellis) preferred
  • Prior experience with staff line management (hiring, training) required

To apply please submit CV in Word format.

Key words: safety reporting manager, pharmacovigilance, safety reporting, 

 

Apply for this job: MANAGER, CLINICAL SAFETY REPORTING - HOME BASED UK/EU

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
SG1 2ST
England
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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