Syneos Health looking for Senior Safety & Pharmacovigilance Specialist
Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Accelerati on Model delivers value across the small to mid-size to large customer continuum.
Post : Safety & PV Specialist I
The position is responsible for the preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and poject/program-specific procedures for clinical trials and/or post-marketing safety programs. Responsible for providing delivery and expertise with minimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead at the project/program level and line manager for deliverables.
• Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents
• Participates in project launch activities for safety reporting tasks
• Prepares Safety Reporting Plan for safety submissions only projects
• Maintain tracking of safety submissions
• Provides Sponsor/Customer with expedited and periodic safety report submission status updates, as required
• Provides support and advice on expedited and periodic safety report issues to project team/Sponsor as required.
• Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
• File documents according to project specific requirements (electronically or in hard copy as applicable).
• Forward completed safety submission documents to clients and other relevant parties
• Acts as a point of contact for regulatory issues related to safety submissions
• May be responsible for distributing and monitoring team workload
• Fosters constructive and professional working relationships with all project team members, internal and external
• Assists in the preparation and participates in internal project review meetings as required
• Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs), related to submissions.
• Participates in audits as required/appropriate
• 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 an understanding and compliance with Standard Operating Procedures (SOPs), Work
• Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
• 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.
• Experience in a clinical research organization preferred with a minimum of 1+years' Safety and Pharmacovigilance experience required including safety submissions
• Safety Database systems experience 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 5%)
Qualification : Bachelor’s Degree in life science, OR Pharmacist
Location : Pune
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance
End Date : 30th August, 2020
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