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SERM (Safety Evaluation and Risk Management) Director

Warren, NJ, New Jersey
Closing date
Oct 15, 2021

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Pharmaceutical, Pharmacovigilance, Physicians/Nurses
Jobseeker Type
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Site Name: USA - New Jersey - Warren Posted Date: Aug 26 2021 Are you interested in a role that allows you to provide strategic guidance and scientific expertise for safety evaluation and risk management strategies of Consumer Healthcare (CH) GSK products in clinical development and/or post-marketing setting? If so, our SERM (Safety Evaluation and Risk Management) Director could be the opportunity you are looking for. This person can work remotely, prefer East Coast area. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Ensures that adverse events and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identifies the need for product labelling updates and drives proactive implementation of risk management initiatives. Provides the opportunity to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimization strategies are included in clinical development programs and innovation projects, show confidence, credibility and influence at all levels of the organization. Presents safety strategy for CH products in assigned therapeutic category at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's Degree in Life Sciences, Pharmacovigilance or related fields 7+ years experience with relevant pharmacovigilance regulations and methodologies applicable to SERM activities Experience evaluating literature reviews, clinical data synthesis including analysis and interpretation. Experience managing multiple strategy formulation and change projects Experience with Pharmacovigilance processes and global Pharmacovigilance regulations Experience in the therapeutic area of assigned GSK products Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD in Life Sciences or PharmD 10+ years experience with relevant pharmacovigilance regulations and methodologies applicable to SERM activities Excellent medical writing skills Experience in the preparation of detailed safety evaluations on products Experience in statistics and epidemiology relevant to assessing drug utilization and safety at the population level In depth knowledge of medical and drug terminology and a sound foundation in pharmacology Experience in the clinical development process Experience in the drug approval process in major countries Proven track record of sound judgement and decision making in causality assessment, evaluation of safety signals, and of proactive risk management strategies including management of labeling changes, physician and patient education and monitoring of safety issues in the real world. 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. *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.
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