About Company
SYNEOS HEALTH is a biopharmaceutical solutions company that focuses on building the latest technologies to offer therapies and medical facilities, making them available for patients faster and easier. The company operates by combining clinical, medical affairs, and commercial trends to address the market challenges. For more details about the company, you can visit on official website of Syneos Health
Interested candidates can apply for the job. All the details are mentioned in the article.
- DEPARTMENT – Pharmacovigilance
- DESIGNATION – Safety & Pharmacovigilance Trainee
- DIVISION – Clinical Research
- EXPERIENCE – Freshers & Experienced
What are the job responsibilities of the personnel?
- Responsible for ensuring the proper vanishing of the patient’s identifying information and pictures according to the data protection guidelines, GCP, ICH, and GVP, only when required.
- Assist in literature screening and reviewing for safety, drug dictionary maintenance, MedDRA coding, and drug coding.
- Accountable for assisting in preparing and submitting documents to the Trial Master File (TMF) as per the company’s Standard Operating Procedures (SOPs) and sponsor’s requirements for clinical trials, and also ensuring submission to the Pharmacovigilance System Master File for post-market programs.
- Observe the translation process for source documents that need translation.
- Responsible for file creation, tracking, retention, and maintaining files in both electronic records and paper formats.
- Manage the information coming for related projects and participate in audits as required.
- Ensure the proper maintenance of the documents and records according to sponsor and customer requirements.
- Validation of xEVMPD product records, including required coding for indication terms using MedDRA, when required.
- Assist in daily working operations as required.
- Conduct manual recording of uncoded products and other substance terms from ICSRs.
- Candidates must be familiar with Standard Operating Procedures (SOPs), Work Instructions (WIs), global regulatory standards for drugs, biologics, and devices, GCP, ICH guidelines, GVP modules, and the complete drug development process.
What qualification is required for the job role?
- Bachelor’s degree in Pharmacy plus Master’s degree in Science (B.Pharm + M.Sc)
- Master’s degree in Pharmacy or Doctorate in Pharmacy (M.Pharm / Pharm D)
- Candidates holding a degree, such as BHMS / BDS / PhD, are also eligible to apply for the job
- Freshers with a deep interest in Pharmacovigilance are welcome to apply for the job.
What are the important skills you must have to acquire this job?
- Strong knowledge and keen interest in healthcare
- Expertise in MS Office and Outlook.
- Good knowledge of Safety Database Systems and Medical Terminologies.
- Excellent Verbal and Oral Communication skills.
- Must be task-oriented as well as skilled in organizing and prioritizing the work.
What is the expected salary for this job role?
Syneo Health officially doesn’t disclose the salary figures for the post of Safety & Pharmacovigilance Trainee, but as per industry standards and job profile, the fresher pharma candidates in the Pharmacovigilance department as Safety and Pharmacovigilance Trainee will be paid up to INR 3.0 LPA
Job Details
- Job Location – Gurugram, Haryana, India
- Contract Type – Full-Time (Contractual)
- Contract Duration – 01 Year (extension possible based on performance)
- Work Type – Onsite
- Company – Syneos Health
- Industry Type – Biopharmaceuticals
- Office Address: SYNEO HEALTH, 4th Floor, Block-2, DLF Downtown, Commercial Site, Block V, DLF City Phase III, Sector 25A, Gurugram, Haryana – 122022, India
How to Apply for the Job?
SYNEO HEALTH invites applications for the role of Safety and Pharmacovigilance Coordinator via an online process. Candidates may apply for the post by filling out an application form using the link mentioned. Shortlisted candidates will receive an email from the HR department for the interview.
Application Link: Click here
