Syneos Life Sciences Safety Specialist Job – Apply Online
Syneos Life Sciences Safety Specialist Job – Apply Online. Freshers BSc Life Sciences candidates with relevant experience to fill the vacancy of Sr Safety & PV Specialist at Syneos. Interested candidates apply for the vacancy given below:
Job Title: Sr Safety & PV Specialist
ID: 20004157
Primary Location Asia Pacific: IND-Pune-Yerwada-Jail-Rd
Other Location Asia Pacific: IND-Hyderabad-Madhapur-Village
Job: Safety & Pharmaco
Schedule: Full-time
Travel: No
Employee Status: Regular
Job Description
- 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 reportability.
- 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.
Qualifications:
- 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%)
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