Parexel, a globally recognized leader in clinical research and regulatory services, is currently seeking qualified candidates for the position of Drug Safety Associate II in Mohali, India. This role is pivotal for individuals with a strong background in pharmacovigilance and a passion for contributing to the global healthcare industry. If you have a Bachelor’s degree in Science or Medicine and relevant experience in the pharmaceutical industry, this opportunity could be the perfect fit for you.
About Parexel
At Parexel, we believe in making a difference in the world of healthcare. Our work spans across clinical trials, regulatory consulting, and market access, all driven by a commitment to improve global health. Every role at Parexel contributes to the development of therapies that benefit patients worldwide. As a Drug Safety Associate II, you will play a key role in ensuring the safety and efficacy of these therapies, working in a collaborative environment that values empathy and excellence.Job Role: Drug Safety Associate II
Location: Mohali, India Position: Drug Safety Associate II Qualification: Bachelor’s Degree in Science or Medicine (or related disciplines) Experience: 2-3 years of pharmaceutical industry experience, with a focus on pharmacovigilance Skills: Strong analytical, problem-solving, communication, and organizational skills; familiarity with GxP requirements and global pharmacovigilanceKey Responsibilities
As a Drug Safety Associate II at Parexel, your responsibilities will include: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
Parexel Pharmacovigilance Vacancies | Drug Safety Associate II[/caption]
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
- Related experience gained in a healthcare environment is an advantage
Eligibility Criteria
Candidates applying for this position should possess:- Educational Background: A Bachelor’s Degree in Science, Medicine, or related disciplines.
- Industry Experience: At least 2-3 years of experience in the pharmaceutical industry, with a focus on pharmacovigilance. Experience in quality compliance or case processing is highly desirable.
- Technical Skills: Proficiency in Microsoft Excel and PowerPoint, and the ability to perform database and literature searches.
