Pharmacovigilance Lead

Pobočka: Lisbon Datum zveřejnění: Jul 26 2022 Main Responsibilities: Contact person for pharmacovigilance (PV) issues at national level. Overall responsibility for the day-to-day management of PV activities for marketed products and products in clinical trials that GSK local operating company is accountable for. Lead, coordinate and maintain the local PV system and operations. Oversight of all PV activities that apply locally. Act as point of contact for the different stakeholders (license partners, CROs, PV service providers,…) Ensure a robust internal control framework and end to end monitoring, assessing the safety risks and addressing effective mitigation plans. Negotiation and creation of local PV Agreements, including due diligence of third parties and assessment of PV requirements on the contracts with third parties. Training and education of GSK staff and service providers, namely on safety reporting. Close collaboration with global safety teams. Acting under the most high-quality patterns driving quality and compliance with regulations and internal requirements. Why you? Requirements: Master’s degree in Pharmaceutical Sciences/Medicine Experience in similar role/pharmacovigilance area of at least 2-3 years Solid knowledge of PV European and national regulation Portuguese (native speaker); English (proficient). Located in Portugal Excellent organization and prioritization skills Agility to adapt and autonomous decision making Ability to build transparent and strong relationships with stakeholders Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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. 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 GSK’s Transparency Reporting For the Record site.