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Safety Specialist Ii
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Updated Yesterday Location Yerawada MH India Job ID 25103877-OTHLOC-5448-2DH Description Safety Specialist II ICSR Case Processing- Gurgaon Hyderabad Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment youa ll collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives Discover what our 29 000 employees across 110 countries already know WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program We are committed to our Total Self culture a where you can authentically be yourself Our Total Self culture is what unites us globally and we are dedicated to taking care of our people We are continuously building the company we all want to work for and our customers want to work with Why Because when we bring together diversity of thoughts backgrounds cultures and perspectives a wea re able to create a place where everyone feels like they belong Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required Assists in the processing of ICSRs according to Standard Operating Procedures SOPs and project program-specific safety plans as required Triages ICSRs evaluates ICSR data for completeness accuracy and regulatory report ability Enters data into safety database Codes events medical history concomitant medications and testsCompiles complete narrative summaries Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved Assists in the generation of timely consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements Maintains safety tracking for assigned activities Performs literature screening and review for safety drug coding maintenance of drug dictionary MedDRA coding as required Validation and Submission of xEVMPD product records including appropriate coding of indication terms using MedDRA Manual recoding of un-recoded product and substance terms arises from ICSRs Identification and management of duplicate ICSRs Activities related to SPOR IDMP Quality review of ICSRs Ensures all relevant documents are submitted to the Trial Master File TMF as per company SOP Sponsor requirements for clinical trials and the Pharmacovigilance System 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 Fosters constructive and professional working relationships with all project team members internal and external Participates in audits as required appropriate Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities Qualifications Bachelora s Degree in life science registered nurse pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge skills and abilities to perform the job Safety Database systems and knowledge of medical terminology required Good understanding of clinical trial process across Phases II-IV and or post-marketing safety requirements ICH GCP GVP and regulations related to Safety and Pharmacovigilance Proficiency in Microsoft Office Suite Word Excel and PowerPoint Visio email Outlook Team Share or another management shared content workspace and internet Ability to work independently and in a team environment Excellent communication and interpersonal skills both written and spoken Good organizational skills with proven ability to prioritize and work on multiple tasks and projects Detail oriented with a high degree of accuracy and ability to meet deadlines Get to know Syneos Health Over the past 5 years we have worked with 94 of all 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 youa ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive The 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 The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above Further nothing 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 comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job Summary Roles within Pharmacovigilance Safety job family are responsible for providing expertise on pharmacovigilance services This includes participating in all aspects of the medical safety team s involvement in assigned trials such as performing medical review and clarification of trial-related Adverse Events providing aggregate reviews of safety information and serving as an internal consultant to pharmacovigilance case processing teams Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees May direct the work of lower level professionals or manage processes and programs The majority of time is spent contributing to the design implementation or delivery of processes programs and policies using knowledge and skills typically acquired through advanced education Entry to developing individual contributor Delivers work of limited scope typically smaller less complex projects Requires theoretical knowledge of a professional area typically obtained through education and or prior experience Share this job
