Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents. For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.
Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).
Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.
In this position the ideal candidate will oversee global pharmacovigilance (GPV) activities, ensuring entire process, program and all activities are conducted in compliance with all internal policies and full range of external regulatory requirements. Responsibilities include:
The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- Directs all global pharmacovigilance activities and safety reporting for all marketed products. Oversee internal work team activities, and external contractors, including global CRO(s), effectively marshalling resources in a matrix organization.
- Ensures that Global Pharmacovigilance (GPV) processes receive, collect, analyze, follow-up and report all individual adverse events, according to local and international regulatory requirements, according to corporate SOPs, and according to good industry practices and all regulatory requirements. Maintain responsibility for drafting new SOPs and presenting these to the SOP review committee in a timely manner, and for appropriate training and documentation of pharmacovigilance staff accordingly.
- Oversees management of our global CRO pharmacovigilance partner and associated staff, and ensure the training, education and performance of these contract staff, as well as internal staff. Collaborate with, and manage the Medical Research Associate(s) in pharmacovigilance.
- Prepares and oversees the timely reporting of events to regulators, and review aggregate summaries and periodic reports (e.g. annual IND updates, PSURs etc.) of summary data. Develop and implement a risk management plan for all products in accordance with regulatory needs.
- Manages the aggregation of data for safety signal detection, for its analysis and their appropriate reporting.
- Stays abreast of current and emerging trends in medical imaging, cardiovascular medicine, and global pharmacovigilance.
- Collaborates with, and maintain effective working relationships with the Medical Information group and the Medical Affairs Field Organization (MAFO) within Global Medical Affairs, as well as cross-departmentally with key stakeholders in Regulatory Affairs, R&D, and Marketing.
- Aligns functional goals and objectives with larger organization goals and business strategy and take actions to achieve them.
- Acts as consultant to the external physician and health care provider communities in communicating the safety profile in aggregate and in individual cases.
- Drives the entire performance management of the GPV function to meet business objectives; allocating and realigning resources, identifying and responding to challenging circumstances.
- Partners with Pre-clinical and with Clinical R&D to better assess and understand the safety profile of marketed products, and in the preparation of safety surveillance activities for pre-market products.
- Leverages a current understanding of global pharmacovigilance regulations and processes, including safety signal detection and phamaco-interact with and work with external physicians and health care providers.
- Maintains current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
- MD required with subspecialty training in cardiovascular medicine, radiology, or internal medicine with cardiovascular or imaging experience and 3+ years Global pharmacovigilance and safety surveillance training and experience, or equivalent.
- MS or MPH an advantage with 7-10 years pharmaceutical industry experience in R&D and, or Medical Affairs or equivalent.
- Routine overnight travel based on business need.