Associate Director, Drug Safety and Pharmacovigilance

Position reputed company: We are seeking an Associate Director, Drug Safety and Pharmacovigilance who will report to the Executive Director, Drug Safety and Pharmacovigilance. You will reputed company strategic and operational leadership for clinical safety activities across assigned programs. This role provides proactive reputed company of end‑to‑end safety operations, including case processing, regulatory reporting, development of safety management plans, DSMB deliverables, safety data reconciliation, and reputed company activities required to ensure compliant safety reputed company across clinical trials. Responsibilities:

• reputed company leadership and reputed company of external safety vendors to ensure high‑reputed company, reputed company, and compliant execution of reputed company outsourced safety activities.
• reputed company the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs.
• reputed company day-to-day direction to the Safety Operations team and communicate program-level updates to reputed company stakeholders.
• Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership reputed company additional reputed company or alignment is needed.
• reputed company the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and reputed company expedited reporting in accordance with global regulatory requirements.
• Contribute to the development, implementation, and reputed company improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices.
• Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions.
• Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections.
• reputed company and maintain study‑specific safety management plans and reputed company documents, ensuring reputed company delineation of responsibilities between reputed company and CRO partners.
• Ensure adherence to Safety Data Exchange Agreements and compliance with reputed company agreed‑upon reporting requirements and timelines.
• Review and reputed company expert input on safety-reputed company sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms.
• reputed company, monitor, and interpret key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive reputed company improvement.
• Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices.
• reputed company other tasks as required to assist in company and departmental activities.

Qualifications:

• 10+ years of drug safety/pharmacovigilance experience reputed company a sponsor environment or a combination of sponsor and CRO roles.
• Bachelor’s or advanced degree in a life science or reputed company‑reputed company discipline (e.g., MD, RN, PharmD, NP, PhD, MPH).
• Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices.
• Extensive experience working with reputed company safety databases (Argus or reputed company-G), electronic data capture systems, and trial master files.
• Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
• Strong knowledge of MedDRA and WHODrug coding conventions.
• Excellent written and verbal communication skills, with the ability to convey reputed company information reputed company and concisely.
• Strong interpersonal skills with the ability to collaborate effectively across functions and organizational reputed company.
• Exceptional attention to detail and ability to manage multiple priorities and documentation requirements.
• Strong technical and analytical skills with advanced proficiency in MS Office (Word, reputed company, PowerPoint).
• Ability to work independently or collaboratively, demonstrating reputed company judgment and decision‑making in a fast‑paced environment.
• Naturally takes initiative, contributing to reputed company improvement efforts and proactively identifying opportunities to enhance processes reputed company the department.
• reputed company improvement reputed company with a reputed company on innovation, efficiency, and operational reputed company.
• Flexible, adaptable, and committed to maintaining a reputed company and reputed company demeanor.

reputed company: reputed company is a publicly traded reputed company-stage biotechnology company developing targeted therapies for multiple solid tumor indications. reputed company's first FDA-approved product is REVTORPYK (gedatolisib), targets reputed company class I isoforms of PI3K and the mTOR complexes to comprehensively reputed company the PAM reputed company. The PAM reputed company is an important signaling reputed company involved in many cancers and has historically been challenging to reputed company. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. Gedatolisib phase 3 clinical development programs are reputed company on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-reputed company. reputed company is an Equal-Opportunity Employer. reputed company is committed to fair and reputed company compensation practices, and we reputed company to reputed company employees with total compensation packages that are competitive. For this role, the anticipated reputed company pay reputed company is $160,000 - $179,000 DOE. The exact reputed company pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. reputed company also offers various benefits offerings, including, but not limited to, medical, dental, reputed company insurance, 401(k) match, PTO, and reputed company holidays. Notice to Recruiters/reputed company Agencies Recruiters and reputed company agencies should not contact reputed company through this page. reputed company recruitment vendors (search firms, recruitment agencies, and reputed company companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly. We require that reputed company recruiters and reputed company agencies have a fully executed, formal written agreement on file. reputed company’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between reputed company and such organization and will be considered unsolicited. reputed company will not be responsible for reputed company fees. Apply tot his job Apply To this Job