Safety & PV Specialist, Future Roles
Safety & PV Specialist, Future Roles
Syneos Health
Job description
Syneos Health is hiring for Safety & PV Specialist: Future role at Hyderabad offering a great opportunity for healthcare professionals.
Company Description
Syneos Health is an integrated life science organisation designed to accelerate their customers’ success. They collaborate with innovation partners throughout the drug development and commercialisation process to help simplify complexity, anticipate changes and drive progress.
Job Summary
As a Safety & PV specialist you will provide pharmacovigilance knowledge. You will perform all aspects of the medical safety team’s involvement in allocated studies. This includes medical review, clarification of Adverse Events related to studies, performing aggregated safety reviews and providing expert knowledge to the pharmacovigilance case teams. The majority of time will be spent performing tasks relating to designing, implementing or delivering processes, programmes and policies using knowledge and skills gained through higher level education.
Key Responsibilities
The key responsibilities of Safety & PV specialist for future roles are:
Maintaining safety tracking for activities assigned.
Carrying out literature screening/review for safety, drug coding and drug dictionary maintenance. MedDRA coding as required.
Validation and submission of xEVMPD product records. Appropriate coding of indication terms using MedDRA.
Manual re-coding of product and substance terms which have not been coded. This will be due to ICSRs.
Identify and manage duplicate ICSRs.
SPOR / IDMP activities.
Quality review of ICSRs.
Ensure that all relevant documentation is submitted to Trial Master File (TMF). This will adhere to company SOP/Sponsor requirements for clinical trials and Pharmacovigilance System Master File for post marketing programmes.
Maintain knowledge and ensure adherence to SOPs, Work Instructions (WIs), Global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/programme plans and drug development processes.
Develop positive working relationships with all members of the project team.
Attend audits as required.
Using the safety reporting regulatory intelligence maintained by Syneos Health in all safety reporting activities.
Educational Qualification
Educational qualifications required for safety & PV specialist: future role are:
Bachelor’s Degree in life science
Registered nurse
Pharmacist or an equivalent combination of education.
Skills required
Skills required for Safety & PV specialist: future 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 salary for a Safety and PV (Pharmacovigilance) Specialist (future role) at Syneos Health in India generally falls between INR 4 LPA to INR 12 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: future 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.