Associate Director - Pharmacovigilance, PV Operations

October 15

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Responsible for the day-to-day management and execution of Drug Safety/PV operations • Responsible for oversight of all aspects of case processing including but not limited to triage, data entry, narrative writing, medical review, follow-up, AOSEs, SUSAR reporting, and query resolution. • Oversee day to day activities related to case processing workflow, safety mailbox, and reconciliation. • Oversee daily interactions with Sponsors, vendors, tracking case progress and adherence to timelines. • Provide technical and case management support to ensure accurate and complete information in the safety database. • Ensure global clinical trial case reporting is efficient and meets safety management plan requirements. • Contribute to aggregate report review and approval. • Develop and maintain pharmacovigilance SOPs and training, and lead quality management and compliance plans. • Track compliance metrics and assist with corrective action plans from audits and inspections. • Prepare and/or review of safety training materials and manage, train and mentor staff, consultants, and/or contractors. • Responsible for coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development. • Assist with the planning, coordination, and management of internal and external safety resources to accomplish assignments to the highest quality standards within the given deadlines. • Participate in regulatory inspections and sponsor/company audits and prepare response to audit findings concerning the Drug Safety department. • Must be able to travel as needed/required • Support Precision leadership in strategic planning and other duties as assigned.

Requirements

• Bachelor’s degree or higher in Health/Biomedical Sciences related field or other equivalent educational training • Minimum of 8-10 years of global Drug Safety / Pharmacovigilance experience in pharmaceutical/biotech industry and/or CRO. • Minimum 5 years managing people • In-depth knowledge of FDA, EU, and ICH guidelines for clinical trials and post-marketing safety. • Proven experience managing pharmacovigilance vendors. • Strong understanding of medical terminology and adverse event assessment principles. • Proficient in using MedDRA dictionary and drug safety systems (e.g., ARISg, ARGUS, Medidata Rave). • Excellent communication skills, with the ability to work effectively across functions and cultures. • Demonstrated ability to think critically, build relationships, and lead or contribute in a team setting, with a commitment to company values and mission. • Experience with case processing in ARGUS • Demonstrated ability to challenge existing practices to become more effective. • Ability to effectively adapt to a variety of situations. • Meet quality and performance standards. • Strong influencing skills • Excellent communication skills, both written and oral • Work effectively as a team member and promotes collaboration. • Demonstrate ownership, initiative and accountability. • Supervisory experience