Novotech Drug Safety Associate Jobs For Pharma, Apply Online
Drug Safety Associate
India
JOB DESCRIPTION
Brief Position Description:
Purpose of Senior Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/post-marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) and preparation of periodic reports & submission in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ ensure compliance with regulations. Assist in developing and implementing best-in-class policies, procedures, and practices within safety management.
Minimum Qualifications & Experience:
- 6 months to 2 years of pharmaceutical/CRO/clinical knowledge/experience with a focus on safety-related areas in clinical trials is required.
Responsibilities:
- Knowledge of clinical trials and pharmacovigilance requirements. Knowledge/experience in international drug safety-regulatory reporting obligations and compliance.
- Experience in coding medical terminologies, case processing, safety report submission is preferred.
- Thorough knowledge of medical terminology and ability to summarize medical information is required.
- Strong computer proficiency and ability to work in specific databases is required/preferred.
- Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.
- Fluent in both written and oral English.
- Good interpersonal skills to professionally communicate with all levels of the organization.
- Good time management & multi-task capability.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.
We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to contacting you regarding your application.
Link to Original Notification to apply
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