Senior Medical Director
7 days ago
Company Overview:
">Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Salary:
">The estimated salary range for this position based in the United States is $201,000.00–$278,900.00 per year.
Job Description:
">- ">
Provides medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements.
">Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators, and project team members, and supports business development activities.
">Reviews and analyzes adverse event data from all sources, including solicited, spontaneous, literature, etc., as contracted.
">Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance, and risk management activities.
">Ensures tasks delegated to pharmacovigilance are properly executed, adheres to applicable regulations and ICH guidelines, and maintains an open line of communication to ensure all procedures are followed appropriately.
">
Required Skills and Qualifications:
">- ">
A background as a formally trained Geneticist with clinical experience.
">Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years).
">Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (comparable to 1-2 years) in the industry.
">Direct experience in safety/Pharmacovigilance (comparable to 2 years).
">Excellent interpersonal skills, influencing and team building skills, and understanding of guidelines (FDA, ICH, EMA, and GCP).
">Working knowledge of biostatistics, data management, and clinical operations procedures.
">Ability to act as a mentor/trainer to other staff within pharmacovigilance, strong decision-making, problem-solving, organizational skills, and analytical skills.
">Excellent oral and written communication skills, working knowledge of relevant safety databases (e.g., MedDRA), and flexibility to travel domestically and internationally for short periods.
">Ability to work independently, analyze work with attention to detail, process, and prioritize sensitive complex information.
">Proficiency in basic computer productivity applications (e.g., word processor, spreadsheets, and presentations).
">Fluent in spoken and written English.
">
Benefits:
">- ">
A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
">Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
">At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
">Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
">Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.
">
Language: en
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