Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)

Job Summary

Required Qualifications

• Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 9+ years (Dir)/12+ (Senior Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
• Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment; Master’s degree preferred.
• Senior Director will have a minimum of Master’s degree with a minimum of 8+ years management experience in a pharma or biotech environment.
• Ability to lead cross-functional team through all activities in the full clinical study life cycle.
• A good understanding of all phases of the drug development process between DSPV, Clinical, Regulatory Affairs, and other functional areas.
• Experience leading and authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs).
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
• Knowledge of drug development process, pharmacovigilance databases and MedDRA coding.
• Understanding of clinical disease state and implications of treatment.
• At ease with data handling and visualization, statistics, and technical writing skills.
• Experience with use of safety databases, preferably Argus Safety Database and signal detection tools.
• Strategic critical thinking skills with focus on data integrity and high-quality outputs.
• Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills.
• Time management skills with ability to prioritize to meet required deadlines.
• Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.
• Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment.
• Ability to work both independently and as part of a multidisciplinary team that is results-oriented.
• Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.