Job details
Job type full-time
Full job description
Company overview
Esperion is a purpose driven company with a singular focus on lipid management for everyoneOur innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative therapies for the treatment of patients with elevated low-density lipoprotein (ldl-c)At esperion, we are passionately committed to bringing complementary therapies to the hypercholesterolemia space that address unmet patient needs in a way that is “patient-friendly, physician-friendly and payer-friendly.”
Esperion’s corporate headquarters are located in ann arbor, miThe company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Position title: senior medical director, global drug safety & pharmacovigilance
Responsible for the medical safety leadership within global drug safety and pharmacovigilance (pv) for assigned investigational and marketed products globallyThe individual will serve as the expert across various functions within the company (clinical research, medical affairs, clinical operations, regulatory affairs, data management, statistics, quality assurance) leading the assessment and provision of key medical safety information for esperion products.
Preferred location: remote – us
Essential duties and responsibilities*
Provide global safety/pv expertise for assigned products through individual and aggregate medical review of cases
Responsible for signal detection and management activities
Represent medical pv and lead safety review committee (src) discussions
Identify and implement proactive safety management strategies
Develop region-specific risk management plans and monitor effectiveness of measures
Contribute to the safety sections of the investigator’s brochure
Represent pv on project and study teams, and other internal teams
Respond to safety queries and interact with health authorities as needed.
Develop and provide strategic safety/pv input into clinical development plans, protocols, clinical study reports, etc.
Provide high quality contributions to safety sections of submission documents
Support preparation for and conduct of advisory committee meetings
Contribute to and review aggregate reports, e.g.: development safety update report (dsur), periodic safety update report (psur)/periodic benefit risk evaluation report (pbrer)
Support ongoing process improvement initiatives by participating in preparation of sops related to medical pv
Support pv operations by providing appropriate process-related medical input and occasional ad hoc individual contributions when necessary to ensure compliance
Remain abreast of advances in medicine, scientific literature and the competitive therapeutic landscape
Maintain in-depth understanding of local and international the regulatory pv landscape
Qualifications (education & experience)
Md/equivalent required with at least 5-7 years of pharmaceutical drug safety and pharmacovigilance experience in global pre- and post-marketing settings
Must have excellent working knowledge of fda and ema regulations, ich guidelines, including understanding of pv quality systems
Have sound understanding of good pharmacovigilance practice (gvp) including pharmacovigilance system master file (psmf) requirements
Strong knowledge of signal-detection and management
Strong knowledge of safety review requirements of investigational and marketing applications, rmps, ibs, protocols, clinical study reports, and other summaries of safety
Solid understanding of safety risk management principles
Strong leadership skills as well as experience working in a matrix environment.
Advanced ability to read, analyze and interpret clinical data and information and safety-related scientific and medical literature
Strong writing skills and advanced verbal communication and presentation skills required
Strong attention to detail in writing and/or proofing materials, as well as in the delivery of internal and external communications
Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Proven track-record of successfully addressing challenging scenarios and comfortably working actively along-side teams on challenging assignments
Experience in the therapeutic area is preferred.
Notice to agency and search firm representatives: esperion therapeutics is not accepting unsolicited assistance from agencies and/or search firms for any job posted on this or a referring sitePlease, no phone calls or emailsAll resumes submitted by an agency and/or search firm to any employee at esperion via email, the internet, or in any other form and/or method without a valid written agreement in place will be deemed the sole property of esperionNo fees will be paid in the event that a candidate is hired by esperion as a result of an unsolicited agency and/or search firm referral.
