Syneos Health Recruitment 2022.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: Senior Safety & Pharmacovigilance Specialist
- Qualification: 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.
Job Description: Greeting from Syneos Health !!!!!
Important Details :
- Location: Asia Pacific – IND-Hyderabad-DLF-Cybercity
- Post of date:14/11/2022
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face interview
- Interview Rounds of Interview: HR
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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.
• Coordinating workflow to ensure delivery of project.
• Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner
• Has an understanding of financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets.
• Prepares Safety Management Plan.
• Assists in the preparation and participates in internal project review meetings as required.
• May enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• May process 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 Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
• Provides training of Investigators on ICSR reporting
• Participate in audits/inspections as required
• 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.
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.
• Safety Database systems and knowledge of medical terminology required
• In depth 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
• Strong communication, presentation, interpersonal skills, both written and spoken
• Strong 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
• Able to make effective decisions
• Minimal travel may be required (up to 10%)