Non-Executive Directors to the Medicines and Healthcare products Regulatory Agency (MHRA)

The Secretary of State for Health is seeking to appoint 3 Non-Executive Directors to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe

As a Non-Executive Director (NED) you will have an important role in working with the Chair and other members to contribute to the work of the Board and to offer, through the relevant officials, appropriate advice to health ministers.

• To provide medical support and input in to the Pharmacovigilance function
• To review serious adverse event (SAE) reports arising from trials
• To maintain the safety profile of study agents, reviewing safety data to identify potential safety issues
• To lead the ongoing safety evaluation process.
• To collaborate and work closely with Medical Sciences to provide a medical input to safety related decisions from a Pharmacovigilance perspective
• To review key clinical trial data documentation
• To provide medical training to Pharmacovigilance function and study teams.

Beating cancer is a real challenge. Here at Cancer Research UK we have 3,500 talented people who are passionate about achieving this vision and thrive in our complex, diverse and dynamic environment. Now we need a results focused Pharmacovigilance Physician to drive the success of our key clinical trials by providing medical support and input in to the Pharmacovigilance function.

About You

You will have an understanding/interest in public health improvement and medicines or medical devices regulation with experience in either biomedical and medical devices, epidemiology/biostatistics or clinical academia.

Remuneration will be £7,883 per annum for a time commitment of 2 to 3 days per month.

The Secretary of State for Health determines the length of appointments, up to a maximum of 4 years.

For more information, please visit the Public Appointments website: http://publicappointments.cabinetoffice.gov.uk/. If you require an alternative format such as braille, large print or audio please call Samantha Alcock on 0113 254 5845 quoting the reference E13-08.

The closing date for applications is midday on 21 May 2013.The Department of Health values and promotes diversity and is committed to equality of opportunity for all.

Regulatory Compliance Executive - Dignity Sciences

Dignity Sciences is an international pharmaceutical company, committed to improving the quality of life for people with diseases for which current therapies are unsatisfactory. Our vision is to enhance people’s dignity and well-being by developing these products through a careful balance of applied pharmacology and clinical science.

The Role and Person: The successful candidate will coordinate, prepare and be accountable for all clinical trial regulatory related activities. They will provide the cross-functional team with regulatory input in order to obtain timely approvals and contribute to the product development strategy planning. They will oversee internal activities and external vendors to ensure compliance with all regulatory requirements. In addition the candidate will be required to provide oversight on vendor audits (GMP, GLP and GCP).

The successful candidate will have a relevant Life Science degree and a minimum of 8 years EU, US Regulatory Affairs and QA experience in a CRO/pharmaceutical company.

The position offers an attractive package to the right candidate.

Candidates are requested to forward their Curriculum Vitae to Dignity Sciences Limited, Trintech Building, South County Business Park, Leopardstown, Dublin 18 or to info@dignitysciences.com