Sr. Manager, Medical Affairs & Pharmacovigilance

Position Specific Details (Posted on Career Site)

The Medical Science & PV Liaison (MSPVL) will provide and receive requested clinical and scientific information to and from members of the provider and payer community (private insurance, payers, medical groups, pharmacies, government agencies, and health systems with drug formularies), in compliance with all relevant company policies. The MSPVL will align with the Managed Market team to provide formulary support for product education. The MSPVL will participate in the strategic development and tactical execution of plans to engage payer opinion leaders (POLs) and act as a conduit for providing accurate and updated clinical, scientific, medical and safety information to Health Care Professionals and other members of the scientific community. MSPVL will also support day to day operations for both clinical drug safety and post-marketing pharmacovigilance (PV), with an emphasis on post-marketing surveillance for Rayaldee.  Operations include ensuring proper processing of adverse events and safety information received from all sources, domestic and foreign, from intake to regulatory submission, for periodic aggregate reports and individual case safety reports.  The MSPVL will assist in maintaining post-marketing database as well as the safety module within an electronic data capture system.  

Company Overview

OPKO Health is a multi-national and diversified life science corporation that owns and operates a set of businesses offering biopharmaceutical, genetic testing, laboratory diagnostics, medical device, contract manufacturing, animal, supplement and nutritional health products and services in 60 plus countries with 5,000 employees.

External Description

• Develop clinical knowledge expertise in the Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) treatment landscape including current treatment strategies.
• Develop and ensure alignment in medical education activities for healthcare professionals and payor organizations through MSL-delivered presentations, participation in medical meetings and other appropriate venues to enhance product and disease state knowledge. 
• Establish and maintain scientific/professional relationships with formulary decision makers, external thought leaders and payer influencers by addressing unsolicited requests for information, providing disease awareness and pharmacoeconomic information, and ensuring a clear understanding of the balanced scientific, clinical, safety and pharmacoeconomic data related to Rayaldee.
• Provide educational presentations and training as required on Managed Care issues to internal and external colleagues.
• Ensure alignment on content of effective clinical presentations provided to internal and external audiences, ensuring presentations are tailored to meet the specific needs of the audience (including appropriate responses to unsolicited requests).
• Ensure efficient information exchange between MSPVL colleagues in the field and office-based clinical, medical affairs and drug safety team members so that key clinical, safety and research issues are identified and communicated to and from industry leaders and the appropriate OPKO departments to help shape company research and development strategies for investigational and commercialized products.
• Identify educational needs within the medical community around CKD-MBD disease state management.
• Maintain clinical expertise through comprehensive education including attendance at relevant scientific symposia and workshops, and review of key journals; and where applicable participation in required internal training, and presentations.

• Adhere to all regulatory and compliance guidelines and company policies in all aspects of scientific dissemination of information, including responses to unsolicited requests for medical information. 
• Intake and triage and follow-up of safety information from all sources (e.g., subjects, patients, healthcare professionals, pharmacies, sales representatives, general public). 
• Completion of cases in a timely manner in accordance with appropriate protocols and regulatory guidelines.
• Ensure compliance with health authority regulations in drug safety data processing and reporting.
• Enter and track safety information in safety databases.
• Code medical terms using standardized medical dictionaries (e.g., MedDRA and WHO Drug); assist with establishing coding conventions.
• Participate in the review and reconciliation of data between safety databases and data migration activities.
• Coordinate database implementation and validation.
• Review product complaints and assess for potential adverse events or any impact on subject safety. 
• Perform literature review activities related to adverse event reporting. 
• Provide information and