Pharmacovigilance Job at Sitero
A rare chance has emerged for qualified medical professionals to join Sitero LLC as a Medical Reviewer specializing in ICSR Medical Review and Drug Safety. This Hybrid Pharmacovigilance Job at Sitero requires an MBBS degree and offers an opportunity to work in a hybrid environment with 1–3 years of clinical practice experience.
About Sitero LLC:
Sitero LLC is an emerging leader in clinical services and software solutions for the life sciences industry. The organization specializes in a diverse range of therapeutic areas and focuses on innovative, technology-enabled solutions that enable clients to concentrate on their core strengths. Sitero’s experienced team provides high-touch services and technology to ensure the safety of all stakeholders across the clinical research community, emphasizing ethics, compliance, and innovation.
Job Details:
- Job Title: Medical Reviewer
- Location: Mysore, Karnataka, India (Hybrid)
- Qualification: MBBS or higher; US/EU PV regulations, CIOMS/ICH preferred
- Experience: 1–3 years clinical practice required; 1+ year Drug Safety/Pharmacovigilance preferred
- Salary: Competitive salary, variable pay, healthcare & retirement benefits
Job Description:
The Medical Reviewer serves as the key contact for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables across both early and late-stage development. The individual will manage cross-functional assessments of benefit-risk profiles and communicate safety information for assigned products. This role requires maintaining medical knowledge and a strong understanding of drug safety and pharmacovigilance regulations.
Key Responsibilities:
- Analyze, review, and interpret safety data, both non-clinical and clinical.
- Perform medical review of ICSRs and other drug safety information from various sources.
- Provide technical and medical expertise in assessing causality of Individual Case Safety Reports (ICSRs).
- Contribute to the generation of aggregate safety reports and ensure compliance with regulatory requirements.
- Develop Standard Operating Procedures and contribute to safety training programs.
- Collaborate with Regulatory Affairs for appropriate reporting of pharmacovigilance information.
- Serve as a subject matter expert for vendors providing drug safety services.
- Train and mentor Pharmacovigilance Physicians and Specialists.
Eligibility Criteria for the Pharmacovigilance Job:
- 1-3 years’ experience in Clinical Practice required.
- 1+ year of experience in Drug Safety and Pharmacovigilance is preferable.
- Medical Degree (MBBS or higher) from a recognized medical school.
Required Skills for the Pharmacovigilance Job:
- Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
- Experience with medical drug safety assessments and safety surveillance activities.
- Proficiency in medical review of ICSRs, including coding and causality assessments.
- Ability to build relationships and collaborate across disciplines.
- Excellent verbal, written, and presentation skills.
- Innovative and collaborative mindset.
The Medical Reviewer role at Sitero LLC is an excellent fit for qualified candidates seeking to advance their careers in drug safety and pharmacovigilance. Interested individuals are encouraged to apply before the deadline to secure their chance to be part of this innovative organisation.
