Syneos Health – Pharmacovigilance Safety & Pv Specialist I Openings

Syneos Health Hiring Pharmacovigilance Safety & PV Specialist I

Location: India-Asia Pacific – IND-Hyderabad-Raheja-Mindspace
Job ID: 25001642

Description

Safety & Pharmacovigilance Specialist I

Job Responsibilities 

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• Assists in the processing of 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.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• 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.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

Qualifications

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.
• should have experience in ICSR case processing activites Safety Database systems and 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 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
• Good communication and interpersonal skills, both written and spoken
• Good 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

Get to know Syneos Health

• 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 73,000 Sites and 675,000+ 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 ever-changing environment

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive

Apply Here

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Careers