Syneos Pharma Safety Specialist Vacancy – Apply Online
Pharma jobs, Pharmacy jobs, Post, Health Jobs, Pharmacy jobs. Syneos Health invites pharma candidates for Research Job Opening. So what are you waiting for don’t miss out this great opportunity? Candidates with Pharmacy filed may apply for this job post via online mode. Check out all the details on the same below:
Job Title: Sr Safety & PV Specialist
QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
Bachelor’s Degree 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%)
- Coordinating workflow to ensure delivery of the 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.
- Triages ICSRs evaluates ICSR data for completeness, accuracy, and regulatory repeatability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications and tests.
- Compiles complete narrative summaries.
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinates with data management staff concerning the 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.
Editor’s Note: Syneos Pharma Safety Specialist Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.