Syneos Health is a biopharmaceutical solutions company that mainly focuses on developing and innovating the latest technologies to help patients, and the company also facilitates therapies and Medical facilities for patients earlier. The company functions 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
Clinical Research Pharmacovigilance Vacancy Details
Syneos Health is hiring candidates for the job role of Safety & Pharmacovigilance Coordinator, for which candidates must fulfil the eligibility criteria to grab this position. Interested candidates can apply for the job. All the details are mentioned in the article.
- DEPARTMENT – Pharmacovigilance
- DESIGNATION – Safety & Pharmacovigilance Coordinator
- DIVISION – Clinical Research
- EXPERIENCE – Freshers & Experienced
Job Responsibilities
- Performing validation of xEVMPD submissions, including proper MedDRA classification of indications when applicable.
- Prepare and submit documents to the Trial Master File (TMF) in accordance with the company’s Standard Operating Procedures (SOPs) and sponsor’s requirements for clinical trials, and also submit to the Pharmacovigilance System Master File for post-market programs.
- Handle the information coming from related projects.
- Ensure the proper removal of the patient’s identifying information and pictures according to the data protection guidelines, GCP, ICH, and GVP if needed.
- Organize and maintain the documents and records according to the sponsor, and customer’s needs.
- Maintains the understanding of 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.
- Support the management of the distribution of incoming faxes and mail when required.
- Assist in literature screening and reviewing for safety, drug dictionary maintenance, MedDRA coding, and drug coding.
- Perform manual recording of uncoded products and other substance terms from ICSRs.
- Accountable for file creation, tracking, retention, and maintaining files in both electronic records and paper formats.
Educational Qualification
- Bachelor’s degree in Pharmacy (B.Pharm) from a recognized institute in India.
- Bachelor’s degree in Nursing or Life Sciences (B.Sc)
- Candidates must be registered under the respective councils, like PCI or NCI.
- Basic Knowledge of MS Excel, PowerPoint, Outlook, and Teamshare.
- Freshers are welcome to apply for the job.
Skills Required
- Proficiency in the Clinical Trial Process
- Good knowledge of Safety Database Systems and Medical Terminologies.
- Capable of Maintaining Confidentiality and Data Security.
- Time Management and Capability of prioritizing tasks.
- Excellent knowledge of regulatory standards.
- Strong Verbal and Oral Communication skills.
Clinical Research Pharmacovigilance Salary
Syneo Health doesn’t state the salary figures for the post of Safety & Pharmacovigilance Coordinator, but as per industry standards and job profile, the fresher pharma candidates in the Pharmacovigilance department as PVG Coordinator will be paid up to INR 3.5 LPA
Other Job Details
- Job Location – Gurugram, Haryana, India
- Contract Type – Full-Time
- Work Type – Onsite
- Company – Syneos Health
- Industry Type – Biopharmaceuticals
How to apply for Syneo Health Clinical Research Jobs
SYNEO HEALTH invites applications for the role of Safety and Pharmacovigilance Coordinator in an online mode. 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.
