Safety & PV Specialist I, Literature review
Safety & PV Specialist I, Literature review
Syneos Health
Job description
Syneos Health is hiring for Safety & PV Specialist role at Gurgaon offering a great opportunity for healthcare professionals.
Company Description
Syneos Health is a fully integrated life science services organisation, created to help its customers succeed faster. They work with innovation partners at every stage of their drug development and commercialisation journey to simplify complexity, predict change and accelerate progress.
Job Summary
The roles of Safety & PV specialist include providing pharmacovigilance expertise. Performing all elements of the medical safety team’s involvement in assigned studies including performing medical review and clarifying Adverse Events relating to studies, undertaking aggregated safety reviews and acting as an expert resource to the pharmacovigilance case teams.
Key Responsibilities
The key responsibilities of Safety & PV specialist I are:
Responsible for tracking safety data.
Perform literature searches and review for safety, drug coding, keeping drug dictionary up to date and MedDRA coding.
Validating and submitting xEVMPD product records including correct coding of indications using MedDRA.
Manually recoding un-coded product and substance ICSR terms.
Identify and manage duplicate ICSRs.
SPOR / IDMP activities.
Quality checking ICSRs.
All applicable documentation to be uploaded into the Trial Master File (TMF) following company SOP/Sponsor requirements for clinical trials and Pharmacovigilance System Master File for post-marketing programs.
Keep up to date with SOPs, Work Instructions (WI), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/programme plans and drug development processes.
Maintain good working relationships with all project team members.
Participate in audits where necessary.
Utilise regulatory intelligence for safety reporting held by Syneos Health.
Educational Qualification
Educational qualifications required for safety & PV specialist I position are:
Bachelor’s Degree in life science
Registered nurse
Pharmacist or an equivalent combination of education.
Skills required
Skills required for Safety & PV specialist I role are:
Knowledge of safety databases and medical terminology.
Good knowledge of clinical trials (II-IV and Post-marketing) and safety requirements, ICH GCP, GVP and regulations relating to Safety & Pharmacovigilance.
Proficient with Microsoft Office (Word, Excel and Power point), Visio, e-mail (Outlook), Team Share (or similar management/sharing content tool) and Internet.
Ability to work autonomously and as part of a team.
Excellent communication skills.
Good organisational skills and must be able to prioritise and multitask.
Attention to detail.
Salary Structure
The average salary given to a Safety and PV Specialist I (Safety and Pharmacovigilance Specialist) at Syneos Health in India is between ₹5 LPA and ₹8.5 LPA.
Career Development
By joining Syneos Health as a Safety and PV Specialist you will have a strong career progression. You will be at the forefront of working with innovative biopharma solutions and global regulations. You will develop your skills by becoming an expert in using industry-leading safety databases such as Argus and ArisG. You will play a key role in signal detection and risk management.
How to Apply
Go to our jobs page and search for the Safety & PV Specialist role at Syneos Health.
Click on the role to see further details.
Complete your details and upload your CV.
Submit your application.
Education
Bachelor's Degree
Key Skills
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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.