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Job Details

Manager Clinical Safety - Hatfield, Hertfordshire

Company: Mylan
Location: Hatfield, Hertfordshire
Reference: MCS001
Closing Date: 28 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits: Excellent

Job Summary:

Overall Job Purpose: To assist in performance of Global Pharmacovigilance activities in relation to clinical safety for Mylan sponsored clinical trials in accordance with company, national and international requirements.


Department                : Global Product Safety & Risk Management

Responsible For       : Senior Drug Safety Officers (clinical) and Clinical Safety Physician

Reporting To             : Global Head Clinical Safety


Main Accountabilities:

  • Accountable for managing and maintaining operational aspects of clinical safety for Mylan sponsored clinical trials, ensuring all the pharmacovigilance obligations are fulfilled and that all the required PV activities are in line to support a particular clinical trial.
  • Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans in liaison with PSRM Teams, therapeutic safety leads & clinical leads ensuring optimal efficiency.
  • Monitoring safety profile of Mylan’s product in development in liaison with clinical safety leads by reviewing all source of safety information including but not limited to SmPC/USPI review of brand leader products for changing safety information, CT cases, literature etc and updating clinical safety leads and global head of clinical safety in a timely manner.
  • Training of the internal PSRM teams on protocols/IB and other safety aspects of a particular trials. Training for data entry, review, reporting of clinical trial cases.
  • In liaison with other team members creating and maintaining repository for Global and Affiliate sponsored studies and periodic follow- up with concerned affiliate/clinical departments/CROs.
  • Maintaining day to day contact with the clinical operations and CROs for the smooth functioning of a particular trial in relation to clinical safety. Active participation in safety related meetings with CROs/clinical operations.
  • Training Investigators on safety reporting aspects of the trial in liaison with clinical leads as necessary.
  • Assisting Head of Clinical Safety and other therapeutic area safety leads in preparation and implementation of Global clinical trial safety templates.
  • Regular updating and working closely with internal PSRM teams for the provision of data for the preparation of clinical safety documents and to make sure all internal teams are aware of the development projects (ongoing /planned) in a timely manner.
  • Preparing case narratives for clinical trial SAEs to be included in clinical study reports and drafting investigator notification letters as required. Cumulative review of safety information.
  • Providing scientific input/review of clinical study protocols, Investigator Brochures, CRFs, ICFs, and Clinical Study Reports
  • Maintaining up to date knowledge for global HA/Ethics requirement, expedited and periodic submissions requirements and training of the team members as necessary.
  • Maintaining and preparation of schedule of periodic reporting (6 monthly Line Listing etc.) and reconciliation in liaison with other team members.
  • To act as a back-up and oversee the team functionality in the absence of Senior Team Members.
  • Writing new SOPs and updating existing ones related to PV Operations and Clinical Safety.
  • Preparation of cumulative safety summary of the SAEs received for a particular clinical trial.
  • Assisting with any other Pharmacovigilance team projects as necessary.
  • Supervise workloads and individual performance of other team members.

Apply for this job: Manager Clinical Safety - Hatfield, Hertfordshire

Contact Information:

Address:  Mylan Global Respiratory Group
Discovery Park House Discovery Park Ramsgate Road Sandwich Kent
CT13 9ND
Tel:  01304 626200
Website:  Visit Our Web Site

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