About Company
NOVOTECH is a Contract Research Organization (CRO) that works with biotech and pharma companies to perform clinical trials of new drugs, Novotecg provides various services like regulatory consulting, patient recruitment, site selection, and clinical operations. For more details about the company, you can visit Novotech CRO
Interested candidates can apply for the job. All the details are mentioned in the article.
Drug Safety Associate Job Details
- DEPARTMENT – Pharmacovigilance
- DESIGNATION – Drug Safety Associate
- DIVISION – Clinical Research
- EXPERIENCE – Freshers & Experienced
Job Responsibilities
- Handle case management activities, write safety reports, monitor the safety mailbox, and organize study documents in the Trial Master File (TMF)
- Engage in audit activities, and support in developing or implementing corrective and preventive actions (CAPA) concerning case processing.
- Perform literature reviews observe adverse event reports, and track post-approval commitments.
- Create safety management plans, prepare safety database documents for individual projects, and prepare presentation slides for project opening meetings.
- Assist with clinical study reconciliation processes as required by the client.
- Submit reports to regulatory authorities on time, ensuring adherence to applicable regulations, and supervising submission data for compliance.
- Coordinate with medical monitors, clients, drug safety physicians, and study teams to clarify necessary details for case processing.
- Provide training and guidance to Junior staff.
- Handle and manage the unbinding activities.
Required Qualification
- Health / Life Sciences / Pharmacy / Nursing / Biomedical Sciences or a related scientific field is required.
- B.Pharm / B.Sc / PharmD / M.Sc / BDS
- PG degrees or Clinical Trial Certifications will be considered a benefit.
Required Skills
- Knowledge of medical terminologies and the ability to summarize the medical content.
- Proficiency in coding medical terminology, safety reports submission, and case processing
- Experience with clinical trials, pharmacovigilance, and global drug safety regulatory reporting and safety compliance.
- Strong interpersonal skills to interact professionally.
- Good Time Management Skills and Multitasking abilities.
- Expert in both written and verbal English.
Drug Safety Associate Salary & Other Details
- The Anticipated Salary as per industry standard is up to INR 4.0 LPA
Disclaimer: The salary figure mentioned is estimated from different websites like Glassdoor, AmbitionBox, etc.
Job Details
- Job Location – Bangalore, Karnataka, India
- Contract Type – Full-Time
- Work Type – Onsite
- Deadline – 28th February 2025
- Company – NOVA CRO
- Office Address: Parexel Clinical Research Organization Company, Ground Floor, Unit 1, Block E, Helios Business Park., Bangalore, 560103, India
How to Apply for Drug Safety Associate Jobs at Novotech Clinical Research?
- Candidates may apply for the post by filling out an application form using the mentioned Link.
Application Link: Click Here
