Director, Data Quality

Site Name: GSK HQ, Mississauga, UK - Hertfordshire - Stevenage, Warsaw SERM Scientific Director Are you interested in a highly visible, strategic role that allows you to support the pharmacovigilance and benefit-risk management of assigned GSK global assets to ensure Patient Safety globally.? If so, this SERM Scientific Director role may be an exciting opportunity to explore. The SERM Scientific Director provides in-depth medical/scientific expertise in the safety evaluation and risk management (SERM) of key GSK assets in clinical development. This role ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. This role makes recommendations for the further characterization, management, and communication of safety risks while focusing on efficiency and effectiveness to meet the needs of our Patients and HCPs. Scientific/Medical Knowledge PV Expertise

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
  
• Leads the safety component of global regulatory submissions.
  
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
  
• Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
  
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
  
• product incidents) and ensures that risk-reduction strategies are implemented appropriately.
  
• Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
  
• Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
  
• Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
  
• SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
  
• In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
  
• Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety or a related field. Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing Clinical Development activities. Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles.Adjustments@gsk.00noon Monday to Friday, during bank holidays these times and days may vary. 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #