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
Primary Location Asia Pacific: IND-Pune-Yerwada-Jail-Rd
Other Location Asia Pacific: IND-Hyderabad-Madhapur-Village
Job: Safety & Pharmaco
Employee Status: Regular
- 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.
- 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%)
Editor’s Note: Syneos Life Sciences Safety Specialist Job – Apply Online. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on all of our social media like Twitter, Facebook and Instagram.