Pharmacovigilance Agreements Manager

Pharmacovigilance Agreements Manager The new Consumer Health Business in GSK is a fastmoving dynamic business, bringing together, as part of a joint venture with Pfizer, two exciting consumer-centric portfolios which include Oral Health, Respiratory & Skin, Pain and Wellness. As the Pharmacovigilance Agreements Manager , you will lead business partnerships and be responsible for co-ordination, end to end evaluation, negotiation, and delivery of Safety Data Exchange Agreements (SDEAs) with Licensing Partners to ensure GSK Consumer Healthcare can meet its drug safety and vigilance obligations and ensure Patient Safety. In addition, you will lead internal projects relevant to SDEAs, change management and make significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance. Key Responsibilities include, but are not limited to: * Manage all end to end SDEA activities with business partners * Act as a contact point for audits, partner assessments and inspections * Prepare, coordinate and deliver SDEA process training to relevant staff across company including LOCs, external PV vendors, legal departments and Business Development * Develop and maintain process documents defining the responsibilities of GSK staff for due diligence of vigilance systems and negotiation and implementation of SDEAs * Develop and maintain Global SDEA templates * Keep up to date on regulatory/legislation changes and implement changes in SDEAs and SDEA processes/template when applicable * Train, coach and mentor junior staff Why You? Essential qualifications and skills: * Bachelor's Degree in life sciences or equivalent * Strong background in Pharmacovigilance at a senior level * Relevant experience in the pharmaceutical industry demonstrating a sound knowledge of pharmacovigilance regulations and safety data exchange agreements (SDEA) * SDEA negotiation experience * Extensive experience & demonstrable ability of negotiation interaction with third parties (e.g., business partners) * Experience working with teams and individuals in other parts of the business in a collaborative manner to develop business solutions and create value * Proven project management skills and change management experience * Experience of internal and/or external audits and inspections Preferred Skills: * Higher degree or PV qualification * Knowledge of Consumer Heath environment including legislative requirements * Project Management skills * Ability to provide innovative ideas to address new issues or improve approaches to existing operations with demonstrated ability to take a lead in driving needed change * Ability to adjust behaviours and priorities based on changing environment * Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes Closing Date for Applications: COB 26 June 2020 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV 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. 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. *LI-GSK Company Details: GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we