Premium Employer
i
This company page is being actively managed by
Navitas Life Sciences Team. If you also belong to the team, you
can get access from
here
Navitas Life Sciences
Compare
All Filters
16 Navitas Life Sciences Jobs
Safety Specialist II
Navitas Life Sciences
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
We are currently seeking a Safety Specialist II to join our growing team. The role will include the following:
Aggregate Reports
- Author and review Aggregate Safety Reports (i.e. DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports) and any other aggregate reports as per requirement of the project.
- Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
- Analyze safety and regulatory data provided by the client and prepare complete Aggregate Reports according to the client requirements.
- Perform literature screening for inclusion of significant safety articles in respective section of aggregate reports
- Compile benefit risk evaluation sections provided by medical reviewers, as applicable.
- Ensure you comply with internal and external timelines
- Address comments from internal and external/client reviewer(s)
- Finalize reports as per client requirements
- Participate in internal and external audits and inspections by clients and health authorities.
Signal Management and Risk Management Plans
- Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement.
- Generation of line listings and summary tabulations from Argus/client safety database.
- Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritization of signals by reviewing available data.
- Ensuring compliance to appropriate signal SOPs, conventions and guidelines for all activities performed.
- Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals.
- Developing Risk Management Plans and associated activities as per Navitas Life Sciences/client specific SOPs
Desirable Skills and Experience
- Ability to author and review Aggregate Safety Reports
- PBRER Aggregate Report experience
- Ably assist and support Individual Case Safety Report team as per the workload in respective teams
- Ably Assist and support Literature review team as per the workload in respective teams
- Assist in the scheduling of reports assigned to the team
- Good understanding of medical and Pharmacovigilance terminologies
- Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations
- Basic competence with medical and therapeutic terminology.
- Strong understanding of patient safety regulatory obligations.
- Familiar with regulatory and pharmacovigilance guideline
- Good command of written and spoken English; additional languages are favorable
- Good knowledge of usual office software (MS Office: Word, Excel, and PowerPoint)
- Soft skills (motivation, strong communication competence, structured in work, organizing skills, reliability commitment and capacity for teamwork)
Graduate or post graduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences and any other additional related courses.
Employment Type: Full Time, Permanent
Read full job descriptionNavitas Life Sciences Interview Questions & Tips
Prepare for Navitas Life Sciences roles with real interview advice
People are getting interviews at Navitas Life Sciences through
People are getting interviews through
(based on 7 Navitas Life Sciences interviews)
Job Portal
Referral
Company Website
43%
29%
14%
14% candidates got the interview through other sources.
Moderate
Confidence
?
Moderate Confidence means the data is based on a sufficient number of responses received from the candidates
What people at Navitas Life Sciences are saying
What Navitas Life Sciences employees are saying about work life
based on 154 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Navitas Life Sciences Benefits
View more benefits
Compare Navitas Life Sciences with
IQVIA
Compare
Parexel International
Compare
ICON Plc
Compare
PPD
Compare
Fortrea Development India Private Limited
Compare
Syneos Health
Compare
Cognizant
Compare
Wipro
Compare
TCS
Compare
Syngene International
Compare
Aragen Life Sciences
Compare
SAI Life Sciences
Compare
Lambda Therapeutic Research
Compare
Reliance Life Sciences
Compare
Aizant Drug Research Solutions
Compare
Veeda Clinical Research
Compare
Rubicon Research
Compare
Cliantha Research
Compare
Accutest Research Laboratories
Compare
Ephicacy Lifescience Analytics
Compare
Similar Jobs for you
Share an Interview