Director, Pharmacovigilance (PV) Scientist

Role Summary

Director, Pharmacovigilance (PV) Scientist. This role combines operational PV support and analytical PV support for clinical trials, focusing on case oversight, signaling, aggregate reporting, and development/maintenance of core study documents for PV. The position sits on core study teams in a cross-matrix environment as an individual contributor.

Responsibilities

• Collaborate with the medical monitor for timely review of SAEs, analysis of similar events, and procurement of follow-up information
• Review, process, and expedite all SAEs in accordance with global regulations
• Lead signaling for assigned products, including facilitating cross-functional Safety Management Committee meetings, setting agendas, creating materials, presenting to the committee, and managing associated documentation
• Provide PV subject matter expertise in all areas of clinical development including core study document development and maintenance (CRFs, ICF, protocols, IBs), regulatory information requests, and safety crisis management
• Lead and author the annual Developmental Safety Update Reports
• Develop and/or support standard operating procedures (SOPs)

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 8 years’ pharmaceutical industry experience in PV
• Knowledge of MedDRA terminology and its application
• Experience reviewing cumulative safety data and ability to interpret, synthesize, and communicate complex clinical/pharmaceutical information
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and safety surveillance activities
• Ability to execute and follow through to completion and documentation
• Ability to work effectively in a collaborative team environment and influence multiple functions
• Independently motivated, detail-oriented, and strong problem-solving ability
• Excellent organizational skills to multi-task in a fast-paced environment with changing priorities
• Excellent communication skills and ability to influence multiple functions
• Experience working on BLA/MAA filings is preferred

Skills

• Pv governance and signaling
• Clinical development documentation (CRFs, ICF, protocols, IBs)
• Regulatory information requests and safety crisis management
• SAE review and aggregation, data interpretation and communication
• Cross-functional collaboration and stakeholder management

Education

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree