Japanese Language Expert - Safety PV Specialist
Japanese Language Expert - Safety PV Specialist
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Japanese Language Expert Safety & PV Specialist
Job Location: India
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Entry level
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 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 FullService 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 to change lives.
Discover what our 29000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
What we’re looking for
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 73000 Sites and 675000 Trial patients.
No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and everchanging 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 Job Description. 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.
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 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 FullService 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 to change lives.
Discover what our 29000 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 – 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 – we’re able to create a place where everyone feels like they belong.
- Coordinates workflow to ensure delivery of project.
- May be responsible for distributing and monitoring team workload.
- Escalates issues with project deliverables finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner.
- Provides support to manage safety and pharmacovigilance project risks/ issues as required.
- Understands financial measures work orders performance metrics (including quality parameters monthly budget reports and changes in scope) and project budgets.
- Assists in the preparation of project plans such as Safety Management Plan.
- Assists in the preparation and participates in internal project review meetings as required.
- May perform setup delivery and closeout of safety and pharmacovigilance projects.
- Maintains safety tracking for assigned activities.
- May enter information into SPVG quality and tracking systems for receipt and tracking ICSR.
- May process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans.
- Triages ICSRs evaluates ICSR data for completeness accuracy 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 generation of timely 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 clinical and safety databases.
- May perform or participate in quality control of literature screening and review for safety drug coding maintenance of drug dictionary MedDRA coding.
- Validation and Submission of xEVMPD product records including appropriate coding of indication terms using MedDRA.
- Manual recoding of unrecoded product and substance terms arises from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Quality review for the work performed by peers.
- Serves as a subject matter expert in SPVG which includes resolution of project related routine queries mentoring and coaching.
- Managing a small team within the project.
- Ensures distribution of all required individual expedited and periodic reports for both clinical and postmarketing projects to the Safety Submissions team if contracted to submit the reports.
- Provides training of Investigators on ICSR reporting or training to project team members for appropriate project related activities.
- Participate in audits/inspections as required.
- 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 postmarketing 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.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
What we’re looking for
- Bachelor’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
- In depth understanding of clinical trial process across Phases IIIV and/or postmarketing safety requirements ICH GCP GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word Excel and PowerPoint) Visio email (Outlook) TeamShare (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment
- Strong communication presentation interpersonal skills both written and spoken
- Strong 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
- Able to make effective decisions
- Minimal travel may be required (up to 10%)
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 73000 Sites and 675000 Trial patients.
No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and everchanging 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 Job Description. 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.
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Employment Type
Full Time
Key Skills
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