Syneos Health Recruitment 2023.Syneos Health Notification full details below..Intrested and eligible candidates can Send Resume.Syneos Health is the only company in the biopharmaceutical services industry purpose-built to create greater success for our customers. At Syneos Health, clinical and commercial live under the same roof and constantly share real world knowledge and insights that lead to getting the job done better, smarter and faster.
- Department: Safety & Pharmacovigilance Specialist I
- Qualification: Bpharm, Mpharm
- Experience: 2 to 6 year(s) of experience
Job Description: Greeting from Syneos Health !!!!!
Important Details :
- Location: Gurgaon/Gurugram
- Post of date:16/08/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face interview
- Interview Rounds of Interview: HR
Safety & Safety & Pharmacovigilance Specialist I Specialist I
Come discover what our 25,000+ employees already know: work here matters everywhere. Were a growing and evolving biopharmaceutical industry leader, which means youll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
• 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.
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.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
o Enters data into safety database.
o Codes events, medical history, concomitant medications and tests.
o Compiles complete narrative summaries.
o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o 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 Safety & Pharmacovigilance Specialist I 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.
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.
Must have 2+ to 6 years of experience in ICSR Data Entry +Argus
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 Safety & Pharmacovigilance Specialist I
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
This is fulltime Office based role, If you are looking for homebased or Hybrid model then please wait for other opportunties. Apply only if you are OK to work from our Gurgaon office 5 days a week