Safety & Pharmacovigilance Specialist II (Night Shift)
About the Role
Company Overview
The Syneos Health company is an international organization that provides various types of services to the pharmaceutical, biotechnology, and healthcare industries. The company helps in the development, approval, and launching of innovative treatments.
Syneos Health has a presence around the world where they combine scientific expertise, clinical trial knowledge, and business strategies to introduce new revolutionary treatments to patients.
Job Summary
Safety & Pharmacovigilance Specialist II is tasked with the management of safety-related drug data as well as ensuring compliance with international pharmacovigilance rules and regulations.
This job includes full-cycle processing of Individual Case Safety Reports (ICSR). This entails intake, triaging, data entry, coding of medical information, review, and submission.
This is a night-shift role. Candidates need to be able to work with tight deadlines with high level of detail.
The candidates will work closely with various stakeholders and clients worldwide. This job is vital for ensuring patient safety by collecting, analyzing, and reporting safety-related information properly.
Key Responsibilities
The candidate will have end-to-end accountability for all safety case management functions. This includes case intake, triaging, checking for duplicates, data entry, and validation in pharmacovigilance databases.
They will assess adverse event reports for completeness, correctness, and consistency, based on set procedures and SLAs.
An important task of the job will be medical coding of adverse events, patients’ medical history, and associated medications based on dictionaries like MedDRA and WHO-DD. Another responsibility of the job will involve drafting clear case narratives and follow-ups where required to get any missing or incomplete data.
The expert will have the responsibility to identify reportable cases and assist in submission of reports to regulators in the stipulated time frame, which include serious and unexpected adverse event reports.
Moreover, the position also entails managing the regulation-related functions like xEVMPD submissions and meeting SPOR/IDMP data management requirements, if any. The maintenance of appropriate documentation in the trial master file (TMF) systems and being ready for any kind of audit is another key responsibility of the position.
The individual selected for the position will be responsible for performing literature reviews and screening of safety data to uncover any possible safety signal. They will be involved in internal auditing and inspections in accordance with the global guidelines for pharmacovigilance, ICH-GCP, and GVP.
Qualification and Skill Requirement
Educational Background
B. Pharm
M. Pharm
BDS
BMS
MBBS
B.Sc/ M.Sc. candidates are not applicable
Should have a strong understanding of clinical and medical concepts.
Experience Required
Minimum 2.6 years for the role of Safety & PV Specialist l
Minimum 4 Years for the role of Safety & PV Specialist ll
Technical Skills
The ideal candidate must understand how pharmacovigilance processes operate, their reporting schedules, and the international regulations. Knowledge of international standards including ICH and GVP would be an advantage.
Good attention to detail and accuracy are required. Candidates should be good communicators. They should be able to handle pressure and work within tight deadlines.
The applicant should also be ready to work night shifts and adapt to the fast-paced working environment.
Salary and Benefits
The remuneration package is based on industry standards for pharmacovigilance professionals. The pay scale for this role is INR 9-11 LPA.
Apart from fixed pay, the employee may benefit from incentives and bonuses depending on their performance. Among the benefits, there will be health insurance and learning and development activities.
Employees are expected to improve their professional skills through training and certification process.
Role Importance and Career Progression
This position is extremely important to the safety of patients through the assessment of risks that may be posed by pharmaceuticals. The pharmacovigilance team is required to identify any risks as well as assess and manage them. It is therefore important for anyone who would like to contribute to the safety of the public. The Safety and Pharmacovigilance Specialist II position will offer practical experience.
Professionals can advance to more senior levels such as senior specialists, quality reviewers, or even leaders, including team leaders or managers. Career development for professionals in this role can also involve moves to the areas of regulatory affairs, pharmacovigilance, and medical reviewers. This professional role will provide the opportunity for professionals to take up global roles and leadership roles in the pharmaceutical industry.
How To Apply
If you are passionate about drug safety and eager to contribute to the healthcare industry, this opportunity is for you. To apply:
Create your account on Jobslly.
Search for the job Safety & Pharmacovigilance Specialist II (Night Shift)/ Syneos.
Upload an updated resume.
Upload any relevant certifications.
Submit the completed application.
The application process should involve ensuring that the resume contains information on pharmacovigilance experience, technical skills, and accomplishments. Selected applicants will then be called for evaluation which could include interviews and other tests.
Early submissions are highly recommended since this is an ongoing recruitment process.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.