Pharmacovigilance (PV) Lead responsible for overseeing PV operations across Rhythm's clinical development and post-marketing products, ensuring high-quality safety data management.
Responsibilities include managing individual case safety reports from trials and post-marketing sources, vendor oversight through KPI monitoring and governance, and contributing to global PV documents such as PBRERs, PSURs, DSURs, and RMPs. The role supports cross-functional safety deliverables, provides input for clinical study documents, and participates in PV strategic planning, process improvements, audits, and SOP development. It also involves mentoring junior PV staff and staying current with evolving PV regulations and industry best practices.
Qualifications include a Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or Biomedical Sciences; 8+ years of PV operations experience, with 3+ years in a global post-marketing setting preferred. Expertise in global PV requirements, GxP, ICH guidelines, MedDRA, and safety databases like Argus is essential. Strong stakeholder interaction skills within matrix environments and excellent communication in English are required.
The position is based in Boston, operating under a hybrid-work model, with some travel expected. The role offers a salary range of $160,000-$240,000, with potential bonuses and benefits. The focus is on supporting Rhythm’s mission to develop medicines for rare neuroendocrine diseases, emphasizing regulatory compliance, safety monitoring, and cross-functional collaboration in a global, innovative environment.
#J-18808-Ljbffr...flexibility are top-notch and include: ~ Competitive Pay ~ Professional Development and Advancement opportunities ~ Health, Dental, & Life Insurance ~401(k) plans with generous match ~ Tuition Reimbursement ~ Daily Pay ~ On-Shift scheduling Your Work...
Mindlink Resources, LLC is looking for a dedicated Hindi Community Interpreter in Portland. This role supports multilingual students and families through onsite and remote interpretation. Ideal candidates have 3+ years of interpreting experience and native-level Hindi fluency...
...Reagan Equine, an equine veterinary practice in Wilmington, North Carolina, is looking for an experienced, horse-savvy Barn Assistant to join our hospital team full-time. You'll be the person who keeps our hospital barn running smoothly and our patients safe, comfortable,...
...At PrizePicks, we are the fastest-growing sports company in North America, as recognized by Inc. 5000. As the leading platform for Daily... ...is seeking a highly motivated and experienced Manager, CRM Marketing. This individual will oversee a team of 2 and will play a pivotal...
...Driver Local Delivery Combination Route Avenel, NJLocal Combination Drivers are responsible... ...route. They will manually unload their trucks using a hand dolly or electric pallet... ...requested by the customer. No previous experience is required and Drivers will receive...