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17.06.2020, Ref.#: 169702
★★★ Safety Scientist (M-SERM Scientist II/Sr Safety Specialist), ПИ ПИ ДИ БЪЛГАРИЯ ЕООД  Вижте визитка на компанията
Месторабота София; Постоянна работа; Пълно работно време; Езици: Английски
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Safety Scientist (M-SERM Scientist II/Sr Safety Specialist)

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 23,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

This is an opportunity for a scientific minded inquisitive individual who is looking for a role that requires analytical thinking and advanced pharmacovigilance knowledge. The role will entail providing safety expertise, input and other support for deliverables and activities associated with signal management, benefit-risk evaluations, management of potential safety issues, and drafting of responses to regulatory authority inquiries on product safety issues. We are recruiting for a Senior Safety Specialist to work within a team of product experts who support post-marketing and developmental product safety surveillance.  


• Conduct investigations in the framework of signal detection, signal validation and signal evaluation:
     o Review and assessment of individual case safety reports and scientific literature 
     o Summarize findings and conclusions in signal evaluations reports 
• Presentation of safety topics to the internal team and client contacts
• Authoring and updating of Risk Management Plans
• Drafting of responses to ad-hoc safety questions from regulatory authorities
• Assisting with the maintenance of safety information within Company Core Data Sheets 
• Supporting Regulatory Affairs Teams:
     o Advising on updates to product information (e.g. Summary of Product Characteristics, Patient Information Leaflet)
     o Reviewing and supporting updates of the relevant safety sections of the product dossiers 
     o Providing safety related responses to regulatory queries received during safety variations and other regulatory procedures
• Supporting PPD’s Safety Writing Team:
     o Provide safety surveillance related contributions for DSURs and PSURs/PBRERs to authors 
     o Review DSURs and PSURs/PBRERs to ensure the scientific integrity
• Drafting of responses to PSUR assessment questions


Education and Experience:
• Bachelor's degree in a Biomedical Science, Pharmacy, Nursing or Medical Technology
• Minimum 3 years of pharmacovigilance experience, with minimum 1 year spent in scientific safety surveillance or aggregate safety report writing
• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job

Knowledge, Skills and Abilities:
• Strong critical, scientific thinking and problem-solving skills
• Scientific/medical writing ability
• Ability to assimilate and contextualize data
• Logical thinking, attention to detail but also pragmatism
     o During mentoring, we encourage a willingness to question things that do not appear correct, making sure we do not over-adhere to template text. We emphasize the importance of making sure that comments and text are logical as well as making medical and scientific sense.
• Good Microsoft Word, Excel and PowerPoint skills
• Broad PV knowledge, including regulatory aspects as applicable to the role.
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
• Ability to maintain a positive attitude
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
• Ability to work effectively within a team to attain a shared goal
• Demonstrates initiative on the individual and team level
• Ability to maintain focus while working within strict timelines
• Ability to gain clear agreement and commitment from others through persuasion and influence   

*M-SERM: Medical-Safety Evaluation and Risk Minimisation
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