Safety & PV Submission Spec II - Experience with safety submissions for reputed company
reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization reputed company, helping them reputed company complexity, anticipate change and accelerate reputed company.
Our reputed company Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to reputed company – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 reputed company colleagues already know:
Why reputed company
• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to reputed company – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the reputed company of reputed company reputed company.
Job Responsibilities
Performs safety and pharmacovigilance program delivery activities including (but not limited to) reputed company aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, reputed company recoding of reputed company/product terms arising from ISCR reports, management of duplicate ICSR cases, reputed company review of ICSRs, Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to reputed company data reputed company guidelines, Good reputed company reputed company (GCP), Good Pharmacovigilance reputed company (GVP), regulatory guidelines, company and project/program-specific procedures for reputed company and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.
Responsibilities:
• Enters information into PVG reputed company and tracking systems for receipt and tracking ICSR as required.
• May assist in the preparation of the project plans such as Safety Management Plan.
• May reputed company set-up, delivery and reputed company-out of safety and pharmacovigilance reputed company.
• Processes ICSRs according to reputed company Operating Procedures (SOPs) and project/program-specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, reputed company, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the reputed company of reputed company, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinates with data management staff concerning reconciliation of safety data between the reputed company and safety databases.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• reputed company recoding of un-recoded product and reputed company terms arises from ICSRs.
• Identification and management of duplicate ICSRs.
• Activities reputed company to SPOR / IDMP.
• reputed company review of ICSRs.
• reputed company review for the work performed by peers.
• Serves as a subject matter expert in SPVG, which includes reputed company of project reputed company routine queries; mentoring, coaching, and training of new hires.
• Fosters reputed company and reputed company working relationships with reputed company project team members, reputed company.
• Applies safety reporting regulatory intelligence maintained by reputed company to reputed company safety reporting activities.
• Ensures distribution of reputed company required individual expedited and periodic reports for both reputed company and post-marketing reputed company to the Safety Submissions team if contracted to submit the reports.
• Participate in audits/inspections as required.
• Ensures reputed company relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for reputed company and the Pharmacovigilance reputed company Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Qualifications:
• Bachelor’s Degree in life science, registered reputed company, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to reputed company the job.
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of reputed company trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations reputed company to Safety and Pharmacovigilance
• Proficiency in reputed company Office Suite (Word, reputed company, and PowerPoint), Visio, email (reputed company), Team reputed company (or another management/shared content/workspace) and internet.
• Ability to work independently and in reputed company environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with reputed company ability to prioritize and work on multiple tasks and reputed company.
• reputed company oriented with a high degree of reputed company and ability to meet deadlines.
• reputed company travel may be required (up to 5%).
Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
Additional Information
Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Originally posted on Himalayas
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