The Director / Senior Director will oversee the implementation and coordination of safety surveillance process and procedures of Puma Pharmacovigilance functional area, including development and review of safety reports, assessment of safety signals, and contribution to clinical and regulatory documents. This included development of proactive strategies to prevent risk and promote safety of patients enrolled in Puma-sponsored studies. Demonstrated knowledge of regulatory requirements (FDA, ICH, EMA, etc.) pertaining to Pharmacovigilance, lead and provide medical safety input of response documents to health authorities inquires, able to deal with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions to communicate with internal and external stakeholder. These activities will be done in close collaboration with Clinical Operations and Regulatory and through the use of best quality and Pharmacovigilance practices.
• To act as a point of contact between Puma Pharmacovigilance, clinical trials operations and contract research organizations (CROs),
• Execute the medical review of SAE reports (narrative, coding, labeling, and causality, company comment) to determine required action. Follow-up on clinically important adverse event reports/adverse events of interest,
• Liaise with VP, Pharmacovigilance to ensure effective functioning of the department including strategic and long-term planning and resource assessments,
• Keep leadership (within and outside Pharmacovigilance) abreast of new developments in safety for developmental compounds,
• Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues,
• High Impact Global Decisions: in conjunction with Head of PV, leads and directs interpretation of safety data from internal and external studies and communicates at senior leadership level the impact of the data in terms of go/no go decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling,
• Partner with functional groups to monitor the safety profile of assigned compound(s),leading the review, preparation and review of single or aggregate SAEs reports and recommend appropriate actions,
• Lead data analysis and draft sections of response documents to health authorities inquires,
• Oversee the preparation of relevant safety documents including signal evaluation reports; annual reports/DSUR, IB, ICF, risk assessment, risk management plan; clinical study reports (CSR), labeling, protocols and ad hoc reports (e.g., SOPs, BP, WI, etc.),
• Provide medical advice and insights to therapeutic team colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports,
• Interact with external experts and regulatory agencies,
• Take responsibility for inspection readiness for medical assessment activities and support regulatory inspections when needed.
• As an Individual contributor, initiate project process improvements that align with pharmacovigilance and corporate objectives,
• Develop and maintain a comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned compound,
• Proactively foster an environment of trust, understanding, learning and development,
• Contribute to the training and mentorship of new Pharmacovigilance colleagues and provide risk
• management training to other audiences (e.g. Clinical Operations, Regulatory, Data
• Management, etc.,) as appropriate,
Skills & Abilities
• Critical thinking and analytical skills and ability to make high level decisions with an understanding of the result or impact,
• Knowledge of medical aspects of pre- and post-marketing drug safety,
• Able to deal with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions.
• Proficiency in the processing, assessment, discussion, and presentation of safety data,
• Ability to seek and utilize information and opinions both inside and outside of Puma to independently solve complex problems,
• Interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse Individuals and groups,
• Ability to achieve personal objectives while meeting departmental standards of performance,
• Demonstrated computer literacy, with experience in ARISg, MedORA, WHO, ARGUS, and management of safety databases for signal detection.
This is an In-house position. The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.
Willingness to travel to various meetings or client sites (CROs), including overnight trips. International travel if required.
Medical Degree required or internationally recognized equivalent.
Minimum of 8 years' experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organization with exposure in pre and-post marketing oncology studies.
Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required.
Minimum of 2 years' experience ln people management and well-developed skills in teambuilding, motivating and developing people.
Experience with ARISg, MedORA, WHO, ARGUS, and safety databases.
Knowledge of principles of epidemiology and statistics will be a plus.