Associate Director, Clinical Safety & Pharmacovigilance

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    "requisitionDescription": "<p style=\"margin-left:0in;\" data-pasted=\"true\"><strong>Harmony Biosciences is recruiting for an&nbsp;</strong><strong>Associate Director, Clinical Safety &amp; Pharmacovigilance</strong> <strong>in our Plymouth Meeting, PA location.</strong> In this role you will be responsible for the operational oversight of pharmacovigilance related to Harmony Biosciences investigational and marketed products. This role is responsible for engaging with a team that performs pharmacovigilance services as well as working cross-functionally to support any risk-management activities. This role will ensure compliance with all company policies and applicable regulatory requirements.</p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><strong>Responsibilities include but are not limited to:</strong></p><div style=\"margin-left:0in;\"><ul style=\"list-style-type: disc;margin-left: 0in;\"><li style=\"margin-left:0in;\">Develop and maintain relevant standard operating procedures and working practice documents related to the processing and reporting of individual case safety reports.</li><li style=\"margin-left:0in;\">Implement and provide ongoing oversight of the services provided by the PV vendor.</li><li style=\"margin-left:0in;\">Collaborate closely with the company Medical Directors in the assessment and medical review of serious adverse events reported with investigational and marketed products.</li><li style=\"margin-left:0in;\">Collaborate with pharmacovigilance vendor(s) and internal stakeholders in the development, review, and approval of aggregate reports (e.g., PADER, DSUR, CSR).</li><li style=\"margin-left:0in;\">Exchange safety data with global business partners in accordance with Safety Data Exchange Agreements.&nbsp;</li><li style=\"margin-left:0in;\">Organize and participate in all aspects of cross-functional Safety Review Committee (SRC) meetings.</li><li style=\"margin-left:0in;\">Develop and deliver adverse event and product complaint training for company employees and external service provider personnel.</li><li style=\"margin-left:0in;\">Provide ongoing oversight of the services provided by Contract Research Organizations (CRO) vendors conducting company-sponsored clinical trials.</li><li style=\"margin-left:0in;\">Develop and maintain Safety Management Plans (SMPs) for planned and ongoing company-sponsored clinical trials.</li><li style=\"margin-left:0in;\">Perform ongoing serious adverse event reconciliation and coding reviews for company-sponsored clinical trials.</li><li style=\"margin-left:0in;\">Participate in investigator meetings to train investigators and site personnel in the collection and reporting of adverse events.</li><li style=\"margin-left:0in;\">Work cross functionally to ensure inspection readiness; serve as subject matter expert during regulatory inspections.</li><li style=\"margin-left:0in;\">Interface with internal stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Legal, and Quality Assurance.&nbsp;</li><li style=\"margin-left:0in;\">Represent Clinical PV in cross-functional study team and program team meetings and interactions.</li><li style=\"margin-left:0in;\">Contribute to and review scope of work and budget for Clinical PV services.</li><li style=\"margin-left:0in;\">Comply with all Corporate Policies, business rules, and contractual agreements as set out and communicated by the company pursuant to good business practice.</li><li style=\"margin-left:0in;\">Comply with all regulations and guidance relevant to Good Pharmacovigilance Practices, postmarketing safety reporting, and IND safety reporting.</li><li style=\"margin-left:0in;\">Perform other duties as assigned by management.</li></ul></div><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><strong>Qualifications:</strong></p><div style=\"margin-left:0in;\"><ul style=\"list-style-type: disc;margin-left: 0in;\"><li style=\"margin-left:0in;\">Bachelor&rsquo;s degree required; Advanced degree in health-care discipline strongly preferred</li><li style=\"margin-left:0in;\">7+ years of Drug Safety/Pharmacovigilance experience in a pharmaceutical company with at least 5+ years&rsquo; experience with case processing, narrative writing, aggregate reporting, signal detection, signal evaluation, and risk management.</li><li style=\"margin-left:0in;\">Experience managing investigational and postmarketing pharmacovigilance activities required</li><li style=\"margin-left:0in;\">Detailed knowledge and experience using a global drug safety database (e.g., ARGUS) and medical terminology and drug product dictionaries (e.g., MedDRA, WHODrug).</li><li style=\"margin-left:0in;\">Detailed knowledge of current US and global pharmacovigilance regulations, guidance, and practice standards.</li><li style=\"margin-left:0in;\">Experience in managing external pharmacovigilance service providers.</li><li style=\"margin-left:0in;\">Experience supervising PV activities performed by clinical trial CROs.</li><li style=\"margin-left:0in;\">An understanding of the drug development process, including clinical trial methodology and GCPs; ability to comprehend clinical study reports and interpret scientific data.</li><li style=\"margin-left:0in;\">Experience with FDA PADE inspections and Clinical PV audit readiness preferred.</li><li style=\"margin-left:0in;\">Strong verbal and written communication skills with the ability to communicate with colleagues, business partners, stakeholders and upper management across varied styles and cultures.</li><li style=\"margin-left:0in;\">Strong computer skills including proficiency in the use of Microsoft Office Suite.</li></ul></div><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><strong>Physical demands and work environment:</strong></p><div style=\"margin-left:0in;\"><ul style=\"list-style-type: disc;margin-left: 0in;\"><li style=\"margin-left:0in;\">Domestic travel is estimated to be no more than 5% of the time for this position.</li><li style=\"margin-left:0in;\">While performing the duties of this job, the noise level in the work environment is usually quiet.</li><li style=\"margin-left:0in;\">Manual dexterity required to use computers, tablets, and cell phone.</li><li style=\"margin-left:0in;\">Occasionally required to sit for prolonged periods.</li></ul></div><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><strong>What can Harmony offer you?</strong></p><div style=\"margin-left:0in;\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left:0in;\"><strong>Medical, Vision and Dental benefits the first of the month following start date</strong></li><li style=\"margin-left:0in;\"><strong>Generous paid time off and Company designated Holidays&nbsp;</strong></li><li style=\"margin-left:0in;\"><strong>Company paid Disability benefits and Life Insurance coverage&nbsp;</strong></li><li style=\"margin-left:0in;\"><strong>401(k) Retirement Savings Plan</strong></li><li style=\"margin-left:0in;\"><strong>Paid Parental leave&nbsp;</strong></li><li style=\"margin-left:0in;\"><strong>Employee Stock Purchase Plan (ESPP)&nbsp;</strong></li><li style=\"margin-left:0in;\"><strong>Company sponsored wellness programs&nbsp;</strong></li><li style=\"margin-left:0in;\"><strong>Professional development initiatives and continuous learning opportunities</strong></li><li style=\"margin-left:0in;\"><strong>A certified Great Place to Work&reg; for eight consecutive years based on our positive, values-based company culture&nbsp;</strong></li></ul></div><p style=\"margin-left:0in;\"><strong>&nbsp;</strong></p><p style=\"margin-left:0in;\"><strong>Want to see our latest job opportunities? Follow us on&nbsp;</strong><a href=\"https://www.linkedin.com/company/harmonybiosciences/\" target=\"_blank\"><strong>LinkedIn</strong></a><strong>!&nbsp;</strong></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\">Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit&nbsp;<a href=\"http://www.harmonybiosciences.com\" target=\"_blank\">www.harmonybiosciences.com</a></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><em>Harmony Biosciences is an Equal Opportunity, e-Verify 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.</em></p><p style=\"margin-left:0in;\"><em>&nbsp;</em></p><p style=\"margin-left:0in;\"><strong>Recruitment agencies please note:</strong> Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV&#39;s submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.&nbsp;</p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\">#LI-Hybrid</p>\n",
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