Syneos Job – Life Science Safety & Specialist Vacancy
Syneos Job – Life Science Safety & Specialist Vacancy. BSc Life Sciences candidates with relevant experience to fill the vacancy of Safety & PV Specialist at Syneos. Interested candidates apply for the vacancy given below:
Job Title: Safety & PV Specialist II
Primary Location Asia Pacific: Asia Pacific – IND-Gurgaon-Cyber-City
Other Location Asia Pacific: Asia Pacific – IND-Pune-Yerwada-Jail-Rd
Job: Safety & Pharmaco
Employee Status: Regular
Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data personal privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
- Enters info into PVG quality and tracking systems for a receipt as well as tracking ICSR.
- Might aid in the preparation of the Safety Management Plan
- Processes ICSRs according to Standard Operating Procedures (SOPs) and also project/program-specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and also regulatory report capability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications as well as tests.
- Compiles complete narrative summaries.
- Assesses information to be queried as well as follows up until information is obtained and also queries are satisfactorily resolved.
- Takes part in the generation of timely, consistent as well as accurate reporting of expedited reports based on applicable regulatory requirements.
- Coordinates with data management staff concerning the reconciliation of safety data between the clinical and safety databases.
- Guarantees distribution of all needed individual expedited and periodic reports for both clinical as well as post-marketing projects to the Safety Submissions team if contracted to submit the reports.
- Participate in audits/inspections as required
- Guarantees all relevant documents are submitted to the Trial Master Data (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), worldwide drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans as well as the drug development process.
- Only immediate joiners
- 2 – 4 Years of case processing experience.
- Preferred experience with Legal Case Processing.
- Have to have experience in safety database – Argus.
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education as well as experience that gives the individual the necessary knowledge, skills as well as abilities to perform the job.
- Safety Database systems as well as 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 associated with Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel and also PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) as well as the internet.
- Ability to work independently and also in a team environment
- Good communication and also interpersonal abilities, both written and spoken
- Good organizational abilities with proven capability to prioritize as well as work on several tasks as well as projects
- Detail-oriented with a high degree of accuracy and ability to fulfil deadlines.
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