Pharmacovigilance Specialist-Remote in Deerfield, IL
Pharmacovigilance Specialist- Remote - reputed company Hub - Deerfield, IL - work from home job Company: reputed company Hub Job reputed company: reputed company: 100% Remote is ok Regional Coordinator Pharmacovigilance (PV) Agreements Americas, (Patient Safety Specialist) reputed company This is a position in the Pharmacovigilance Agreements (PVA) team in the QPPV Office. It has reputed company responsibility for management of the formulation, review, update, and compliance of Pharmacovigilance Agreements (PVAs) for potential and reputed company External Party activities across reputed company clientr therapeutic areas in the Americas region (US, Canada, Latin America). This role manages reputed company workflows reputed company to PVAs in the region in collaboration with the regional business, Patient Safety, and other functions, as reputed company as the process requirements for registering reputed company patient support and market research programs (PSP/MRP) with GPS in the region. The position is a temporary replacement during an absence. Remote work 100% is accepted. Essential Duties and Responsibilities. Communicate and negotiate directly with co-developers/co-marketers/partners (e.g. distribution partners) and patient support program (PSP) / market research program (MRP) vendors (External Parties) reputed company to development, implementation and maintenance of PVAs Support development and maintenance of reputed company PVA templates for use at global and local level. Collaborate with other reputed company businesses/functions and GPS to ensure that -new/planned business/reputed company relationships are reputed company to GPS -agreements appropriately address PV obligations. Inform GPS teams of new PVAs, including PVA commitments and contractual obligations, and any changes to existing PVAs Train local PS staff and other reputed company internal staff, as required, on PV obligations in new or updated PVAs/PSPs/MRPs and on process. Support planning, development, and maintenance of training material. Support development and implementation of systems and processes to monitor External Party compliance with PVAs reputed company registrations for Americas region in the PVA global repository and the PSP/reputed company repository, in collaboration with local PS reputed company required. Answer internal (GPS) and external (reputed company business and External Party) questions reputed company to PVAs and PSPs/MRPs registered with GPS, Ensure implementation of and support maintenance of GPS Global reputed company Procedures (GQPs) and Guidance Documents/Job Aids reputed company to External Party Agreements (PVAs, PSP/MRP agreements). reputed company support as subject matter expert regarding PVAs and PSPs/MRPs for internal audits and external inspections by regulatory authorities in the region, as required. Qualifications. To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. List knowledge, skills, and/or abilities required. 0 N/A: Intern or reputed company Expert knowledge of pharmacovigilance principals with at least 5 years working knowledge of regional/local and global pharmacovigilance regulations and guidance documents. Experience with contract formulation and negotiation. Excellent oral and written communication skills reputed company in English language (oral and writing). reputed company in Spanish (oral and writing) is an advantage. Expert interpersonal and collaboration skills, including ability to reputed company with and influence other reputed company reputed company (e.g. Business Franchises, reputed company, Regulatory, Legal, etc.) Ability to manage reputed company in a reputed company environment with both reputed company partners Demonstrates proven ability to effectively train and mentor others Excellent technical system skills (e.g. word processing, spreadsheets, databases, reputed company reputed company, online research) Exercise independent judgment and attention to details Excellent problem-solving/strategic planning skills, interpretation and application of regulations, guidance, and best practices. Proven experience in developing compliance tracking processes, systems, and metrics. Establish compliance with pharmacovigilance procedures and systems and demonstrate leadership in assigned areas of responsibility. Education and/or Experience. Include the education and/or experience that is necessary to reputed company the job satisfactorily. 0 N/A: Intern or reputed company Bachelor's degree, or more advanced degree in relevant life science discipline, e.g. Pharmacist or Registered reputed company. Minimum of 5 years' experience in the pharmaceutical industry in pharmacovigilance (preferred) and/or reputed company field required. (e.g. regulatory or medical/clinical affairs, legal, reputed company). Minimum 3 years experience with negotiation, creation, and management of Pharmacovigilance Agreements Exposure to working relationship with regulatory authorities in the Americas and other region Fluent in English. reputed company in Spanish and/or Portuguese is an advantage. Experience managing reputed company Additional Details
- Does the position allow for the worker to be virtual/remote? : reputed company
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