Drug Safety & Surveillance Specialist Job Job in Memphis, Tennessee US
Drug Safety Surveillance Specialist Job
Drug Safety Surveillance Specialist-DRU000170 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Drug Safety Surveillance Specialist is responsible for preparation, analyses, and follow-up of adverse event (AE) and serious adverse event (SAE) reports for domestic and international OTC products in compliance with company Standard Operating Procedures and applicable guidelines. Assure data accuracy, clinically valid case assessment and regulatory reporting status assessment. May serve as a primary point of contact for specific projects, in addition to providing Safety support and expertise on cross-functional project teams. Duties include and are not limited to the following: * Triage of incoming adverse event reports for completeness, legibility and validity. Assessment of case reports for seriousness, causality and expectedness. * Writing case narratives. * Process and perform medical assessment and reviews for medical/regulatory content. * Assure accuracy per protocol requirements, requesting follow-up as necessary. * Assess and triage of literature and media reports. * Interact with Regulatory Affairs on issues pertaining to submission of appropriate reports to FDA and with Quality department on issues pertaining to quality investigation requests. * Assist with developing project specific safety database customization and data entry guidelines. * Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. * Alert manager to potential signals, such as an unusual number of similar reports. * Bring serious or potentially serious adverse event complaints and any Drug Safety-related issues to the attention of management as necessary and appropriate. * Participate in professional and departmental meetings providing medical input and recommendations for improvement. * Act as the Medical Monitoring Representative in project teams, as appropriate. * Act as mentor, and direct workflow as appropriate to Drug Safety Surveillance Coordinators and Drug Safety Surveillance Specialists. * Assist in supporting inspections and audits. * Assist with staff training and mentoring. Accountability for delivery of results. * Recognize potential or impending problems and work with manager to implement solutions. Qualifications Education: * Requried: Associate's degree (or LPN), preferably in scientific field. Required: * Minimum (2) years pharmacovigilance related or healthcare work experience. * Knowledge and/or experience in drug safety and the drug development process. * Excellent verbal / written communication skills. * Decision-making skills. * Experience with computer applications including database management and pharmacovigilance related computing systems. * Excellent team / project leadership and delegation skills. * Proactive approach/uses own initiative appropriately. Preferred: * Applied knowledge of global regulations and global compliance timeline desired. * Strong understanding of and ability to interpret and apply global safety regulations. * Flexibility and adaptability with a positive attitude. * Proficient in Microsoft Excel and Word. * Experience in MedDRA coding. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. merck.com/careers to create a profile and your resume for requisition # DRU000170. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location: US-TN-Memphis Employee Status: Regular Travel : Yes, 10% of the time Number of Openings: 1 Shift (if applicable) : 1st *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Merck prefers that you apply to this job directly on their site