Safety & PV Specialist I Medical Device & PQC
About the Role
Company Overview
Syneos Health is an internationally renowned biopharmaceutical solution provider. It offers integrated solutions for clinical development, medical affairs, and commercialization. It collaborates with pharmaceutical, biotechnology, and medical device organizations. It works to expedite the provision of treatments to patients.
This organization has a presence in more than 100 countries. It operates in all phases of development of drugs and devices. Syneos Health incorporates clinical, regulatory, and technological expertise into its services.
It is dedicated to offering patient-centric solutions along with quality services. Its employees have a collaborative and performance-driven culture.
Job Summary
The core responsibility of the Safety & Pharmacovigilance Specialist I is the management of safety data and pharmacovigilance process activities with respect to medical devices and product quality complaints. The position will involve end-to-end processing and management of ICSRs.
Requirements of the position
The ideal candidate will be required to manage safety cases, maintain data integrity, and carry out regulatory reports. Handling of PQC cases in relation to medical devices and knowledge of the medical devices safety process will be highly valued in this position.
Key Responsibilities
The candidate is supposed to perform end-to-end processing of individual case safety reports, which involves data entry, triage, case report assessment, and reportability. This will include data entry and management within safety databases such as Argus or ARISg. The candidate is supposed to code adverse events, medical history, concomitant medication, and laboratory data using MedDRA and other dictionaries.
The candidate is expected to produce detailed and medically accurate narrative descriptions of safety cases. This entails assessing missing or conflicting data and ensuring data completeness through follow-up on queries. Duplicate case identification and management and safety reports quality check will be among the duties of the individual.
Support of regulatory reporting processes through preparation and submission of expedited safety reports in accordance with global regulations will be among the responsibilities of the candidate.
Individuals will be responsible for maintaining safety tracking systems and completing assigned tasks on time. Duties also include providing assistance in literature screening and safety reviews. The applicant should be able to maintain drug dictionaries and coding and reconciliation tasks.
This position requires individuals to comply with SOPs, Work Instructions, and international standards such as ICH-GCP and GVP. Individuals will have to participate in audits and inspections. This position entails working effectively within internal teams and external parties.
Qualifications and Skill Requirement
Education:
B.Pharm/ M.Pharm/ PharmD
BDS
BMS
MBBS
This job requires at least 2.5 - 4 years of experience in the field of Pharmacovigilance/ Drug Safety. Experience in dealing with PQC cases is mandatory.
Hands-on experience with safety databases like Argus and ARISg is required.
Knowledge of Pharmacovigilance procedures and processes, Medical Devices Safety, and Regulatory aspects is mandatory. Clinical trials process knowledge is an added advantage.
Candidate needs to be detail-oriented. They should be able to multitask.
Communication and interpersonal skills are required to work with cross-functional teams.
Microsoft Office skills are required along with Data Handling skills.
Salary and Benefits
Syneos Health offers competitive compensation based on experience and role level. The salary for this role is INR 7-10 LPA.
Advantages for employees arise when working within a global CRO setting and getting experience in international projects and varied therapeutic areas.
There are training and development programs offered by the organization as well as mentorship provided to the employees. Health insurance and performance incentives can be among the benefits enjoyed by the employees.
Role Importance and Career Growth
It plays an important role in ensuring patient safety and compliance with regulations in pharmacovigilance and medical devices. Proper management of safety data is important in making submissions and risk management.
The job allows for exposure to international pharmacovigilance and regulatory systems. It gives room for gaining expertise in safety data management and medical device vigilance.
Career progression includes roles such as:
Safety & PV Specialist II
Senior PV Specialist
Drug Safety Associate, or
PV Team Lead
Why Join Syneos Health
Syneos Health provides a collaborative and innovative workplace. The employees contribute to developing important solutions in healthcare that make an impact on people across the globe.
The organization provides opportunities for continuous learning and development. The employees get an opportunity to collaborate with international teams and modern pharmacovigilance systems.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Safety & PV Specialist I – Medical Device & PQC/ Syneos Health.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Applicants should highlight their experience in pharmacovigilance, ICSR processing, and product quality complaint handling.
Early application is recommended as positions may close once filled.
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.