Syneos Health Released Job Openings On 17/08/2022. 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.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.
Vacancy Details:
Syneos Health Recruiting Bachelor’s Degree in life science, registered nurse, pharmacist with 06+ years of Experience for Pharmacovigilance & Senior Safety Specialist Position.Complete Details for the Pharmacovigilance & Senior Safety Specialist as follows.
Important Details :
- Location : Pune
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application:17/08/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
Job Responsibilities
- 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.
- 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.
- 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 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
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
- Should have 6+ years of working experience in ICSR Case processing related activities
- Should have working experience on QC related activities
- Should have working experience workflow management related activities
- 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
