Our client is multinational specialty pharmaceutical company with a diverse product portfolio with focus on branded pharmaceuticals, branded generics and over-the-counter products. Specialization in dermatology, eye health, neurology and consumer healthcare
The incumbent, with limited supervision, will be responsible for drug safety surveillance and signal detection in support of Pharmacovigilance and Risk Management activities for products throughout the life-cycle. The ideal candidate will have an MD or DO as well as previous experience with drug safety data, pharmacoepidemiology, and signal detection.
- Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals and validate. Contribute to analyses in external databases using data mining methods for detection and evaluation of safety signals. Assist in aggregate safety data review and preparation of signal assessment reports.
- Coordinate/co-author the finalization of regulatory documents such as RMPs/REMS, PSURs, DSURs and Ad hoc requests from regulatory agencies.
- Provide strategic and proactive safety inputs into clinical development plans including protocols, CSRs, IB, and informed consent.
- Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines. Develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
- Operate as a liaison with internal stakeholders, including members of Clinical, Medical Affairs, Data Management, Statistics, and Regulatory Affairs, in a matrix environment as needed for specific project needs / plans.
- Thorough knowledge of databases and query software (e.g., FAERS, VigiBase, NHANES, National Poison Data System, Drug Abuse Warning Network, BRFSS).
- Knowledge of statistical software and use of drug safety database, preferably ARISg, AgSignals.
- Proficiency in all Microsoft Office Suite products is essential.
- Excellent interpersonal skills; written, verbal, and analytical skills; and a willingness to work in a team environment. Must demonstrate consistent attention to detail, be highly organized, and demonstrate understanding of work-flow prioritization.
- Knowledge of clinical safety and Pharmacovigilance regulations and guidelines.
- Knowledge of scientific terms and medical terminology.
- Advanced degree MD, DO, or PhD
- years of clinical experience and 1-2 years of relevant pharmacovigilance work experience
Company offers an extremely competitive salary & benefits package.
Base salary Sr. Manager $100-$125k; Director $160k-$170k with bonus and stock.
For immediate consideration, please email resume to firstname.lastname@example.org