Syneos Health Life Sciences Jobs – Apply Online
Are you fluent in Japanese and passionate about patient safety in clinical research? Syneos Health is hiring a Safety & Pharmacovigilance Specialist I in Gurugram, India. As a global leader in biopharmaceutical solutions, Syneos Health offers a dynamic and inclusive work culture with exciting career growth opportunities. This role is ideal for professionals with a background in life sciences and experience in pharmacovigilance who are looking to make a meaningful impact in global drug development. Syneos Health Life Sciences Jobs – Apply Online
Safety & PV Specialist I (Japanese Language Expert)
Updated: Yesterday
Location: India-Asia Pacific – IND-Gurugram-DLF Downtown
Job ID: 25003480
Description
Safety & Pharmacovigilance Specialist I
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 centers the customer and the patient. We continuously seek ways to simplify and streamline our work to make Syneos Health and us easier to work with and for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’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 about changing lives.
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 a total rewards program.
We are committed to our Total Self culture, where you can authentically be yourself. This culture 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. When we bring together a diversity of thoughts, backgrounds, cultures, and perspectives, we’re able to create a place where everyone feels like they belong.
Job Responsibilities
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Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required.
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Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
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Triages ICSRs and evaluates ICSR data for completeness, accuracy, and regulatory reportability.
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Enters data into the safety database.
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Codes events, medical history, concomitant medications, and tests.
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Compiles complete narrative summaries.
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Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
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Assists in generating timely, consistent, and accurate reporting of expedited reports following applicable regulatory requirements.
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Maintains safety tracking for assigned activities.
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Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
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Validation and submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
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Manual recoding of unrecoded product and substance terms arises from ICSRs.
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Identification and management of duplicate ICSRs.
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Activities related to SPOR / IDMP.
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Quality review of ICSRs.
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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.
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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.
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Fosters constructive and professional working relationships with all project team members, internal and external.
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Participates in audits as required/appropriate.
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Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications
What we’re looking for:
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A bachelor’s Degree in life science
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Safety Database systems and knowledge of medical terminology are required.
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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.
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Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet.
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Ability to work independently and in a team environment.
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Excellent communication and interpersonal skills, both written and spoken.
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Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
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Detail-oriented with a high degree of accuracy and ability to meet deadlines.
Get to know Syneos Health.
Over the past five 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 your role, you’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 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 Job Description. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, the 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, concerning 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.
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