Safety Evaluation

At GSK we have bold ambitions for patients aiming to positively impact the health of 2 5 billion people by the end of the decade Our R D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform people s lives GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success We re uniting science technology and talent to get ahead of disease together Find out more Position Summary The SERM Scientific Director will provide in-depth medical scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and or the post-marketing setting 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 Makes recommendations for the further characterization management and communication of safety risks Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally Key Responsibilities Scientific and 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 Explores positions and alternatives to reach mutually beneficial agreements and solutions Cross Functional Matrix Team Leadership Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings Anticipates detects and addresses product safety issues e g 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 Authors participates in written standard updates e g SOPs to ensure policies and regulations are being adhered to correctly and consistently Accountable for the escalation of issues and communication on safety matters e g GSB CHSLC GLC QPPV Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team with a demonstrated ability to lead a team in a matrix setting Ability to coach and mentor others Communications and Influencing Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees Has the skillset to interact with confidence credibility and influence at all levels of the GSK organisation 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 Leads cross-functional process improvement team within GSK Thinks tactically strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements Contributes to development of long-term strategy for clinical programs Regularly contributes innovative ideas to address new issues or improve approaches to existing operations Leads inspection readiness and prepared as needed to support audits inspections Why you Basic Qualifications We are looking for professionals with these required skills to achieve our goals Bachelor s Degree Required MBBS MD Experience in vaccines pharmacovigilance Experience in safety signal detection for vaccines and experience preparing scientifically robust benefit-risk and signal assessments for vaccines Comprehensive experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management encompassing both clinical development and post-marketing activities Knowledge experience of international pharmacovigilance requirements e g ICH GVP modules CIOMS initiatives and drug development and approval processes Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people Inclusion at GSK As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process Please contact our Recruitment Team at to discuss your needs 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 It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for 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