Drug Safety Associate I

0-3 years

Not Disclosed

Chandigarh

15 June 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Assignment Category - Agency Temp (1 Year Contract)
Location - Chandigarh (Office Based)
Shortlisted candidates will be invited to our Chandigarh/Mohali for a face-to-face round of interview.

Key Accountabilities:

Drug Safety Support:

Assist in development of project specific safety procedures, workflows and template
Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
Triage incoming reports for completeness, legibility, and validity
Electronic documentation and quality control of drug safety information
Data entry of case reports into safety database / tracking system
Request follow-up and perform query management
Coding of data in the safety database
Writing case narratives
Create and maintain project specific working files, case report files and project central files
Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required
Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
Participate in client and investigator meetings as required
Attend internal, drug safety and project specific training sessions
Perform literature searches
Preparation for, participation in, and follow up on audits and inspections
Delegate work as appropriate to Drug Safety Assistants
Assistance in development of Expedited Reporting Procedures
Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
Submission of safety reports to investigators via ISIS (International Safety Information System)
Assist with measuring investigative site performance in conducting required tasks in ISIS
Tracking and filing of submission cases as required
Assist with unblinding of SUSARs, as required
Support collection and review of metrics for measuring reporting compliance

Skills:

Analytical and problem-solving skills
Able to perform database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills
Ability to work collaboratively and effectively in a team environment
Client focused approach to work
Experience with computer applications

Knowledge and Experience:

Fresher/ Related experience gained in a healthcare environment is an advantage

Education:

Masters in Pharmacy, Bachelors in Dentistry.

Latest Jobs

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Australia & England & Europe & Ireland & Remote & Saudi Arabia

Drug Safety Associate I

Job Description

Latest Jobs

Pharmacist

Regulatory Affairs Associate

Clinical Scientist

Associate Director, Global Drug Safety & Pv Scientist

Regulatory Affairs Specialist Project Lead I (Scientific)

Pharmacy Analyst

Associate Ii, Compliance - Qa

Clinical Operations Associate

Ctms Ba (Speak - Japanese Language)

Assoc Director Heor

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Australia & England & Europe & Ireland & Remote & Saudi Arabia