Director, SERM

Site Name: USA - North Carolina - Research Triangle Park Posted Date: Jun 24 2021 Are you energized by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this Safety Pharmacovigilance Director role could be an ideal opportunity to explore. As a Safety Pharmacovigilance Director, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level supporting critical and exciting research for Benlysta. This role will provide the opportunity to lead key activities. These responsibilities include some of the following: Safety Governance and Risk Management activities Drives pharmacovigilance and risk management strategy in the clinical matrix team Leads safety input into benefit-risk assessments and risk management plans Delivers the clinical safety input into clinical development planning activities Represents SMG on cross functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional teams to address urgent and important product safety issues Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and data monitoring committee charters. Leads or participates in discussion at Global Safety Board for safety related issues. Presents safety information at clinical investigator meetings, commercial meetings, matrix team meetings, regulatory authority meetings, and at governance boards. Participates or chair the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the Pharma Safety Head. Accountable for ensuring that risk minimization strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate. Signal Detection, Evaluation and Labeling Drives signal detection for assigned products 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 Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board Produces regulatory supporting documentation for labelling updates Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion Regulatory Reports and Submissions Drives production of periodic regulatory documents (PBRERs, DSURs) according to the agreed process and timelines. Supports the Local Operating Companies by preparing license renewal documentation as required for each market Leads the Pharma Safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts Other Pharma Safety Activities Drives the review or production of the Pharma Safety component of Safety Data Exchange Agreements and escalates any deficiencies to the Pharma Safety Head to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility Participates in due diligence activities by providing expert safety assessments and recommendations Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities Provides support to GSK Legal for product liability litigation, as appropriate Accountable for maintaining personal readiness in response to internal audit or regulatory inspection Leads a process improvement initiative within SMG. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation Raises concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; Trains, coaches and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in Health Care related specialty, advanced degree preferred Regulatory submission experience Prior pharmacovigilance experience in SERM related pharmacovigilance activities Expert evaluation skills and analytical thinking Outstanding medical writing skills and sound computing skills Experience working with relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety activities Experience in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education Experience using medical and drug terminology and a sound foundation in pharmacology Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Healthcare related degree Prior clinical experience Previous development experience 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 Clear understanding of clinical development and drug approval process in major countries Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor Ability to manage and co-ordinate tasks, projects and processes across a large organization. Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK Highly developed negotiating and influencing skills Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.