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GSK

Safety/Pharmacovigilance Director

A fantastic opportunity has arisen for a Pharmacovigilance Director to join GSK to provide high level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post- marketing setting

The core purpose of this role will be to ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives

Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.

RESPONSIBILITIES:

Safety Governance and Risk Management activities;
• Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit- Risk Management Plans for designated products
• Leads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
• Delivers the clinical safety input into clinical development planning activities
• Represents SMG on cross functional Clinical Matrix Teams and/or Project Teams.

Signal Detection, Evaluation and Labelling;
• Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
• Makes recommendations to Pharma Safety Team Leader for the assessment and prioritisation of safety signals.
• Proactively leads the assessment of safety data and discusses the results with the Pharma Safety Team Leader/ product physician and safety scientist.
• Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations.

Regulatory Reports and Submissions;
• Drives production of periodic regulatory documents (PBRERs, DSURs) according to the agreed process and timelines.
• Advises on strategy for the content of high profile PBRERs.

Closing date for applications:28th February 2019

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Why You?Basic qualifications:
• Degree in Biomedical or Health Care related speciality
• Prior clinical experience preferred
• Prior experience in pharmaceutical industry, preferably pharmacovigilance, preferred
• Expert evaluation skills and analytical thinking
• Outstanding medical writing skills
• Sound computing skills
• Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety
• activities
• Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
• Sound knowledge of the therapeutic area of assigned GSK products
• Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
• Clear understanding of clinical development process
• Clear understanding of clinical development process
• Clear understanding of drug approval process in major countries

Preferred qualifications:
See above

Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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