Senior Manager/Manager - Medical Review
soterius· Manager, TL. Head
About this role
Job Overview:
Accountable for the medical review function of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Reports to the Director Safety and leads the medical review team, owning the medical quality and clinical judgment applied across the case and aggregate report portfolio.
Key Responsibilities:
1. Lead and own the medical review function across the case processing and aggregate report portfolio.
2. Manage a team of drug safety physicians, ensuring consistency and quality of medical judgment.
3. Provide medical review for serious cases and line listing review for non-serious cases in line with program SOPs.
4. Own causality, seriousness, and expectedness assessment standards across the operation.
5. Provide medical input and benefit-risk evaluation for aggregate reports.
6. Serve as the senior medical point of contact for the client and respond to medical aspects of regulatory queries.
7. Support signal assessment and product safety evaluation for the consumer health portfolio.
8. Ensure the medical review function remains inspection-ready and support regulatory inspections and audits.
Key Skills - Medical review leadership | Drug safety physician expertise | Causality and benefit-risk assessment | Line listing review | Aggregate report medical input | Product safety | Consumer health and OTC | Regulatory query response | Team leadership
We are an equal opportunity employer committed to fostering a diverse, inclusive, and respectful workplace. We welcome applications from all qualified candidates and do not discriminate on the basis of race, colour, religion, gender, gender identity or expression, sexual orientation, age, disability, marital status, or any other characteristic protected by applicable law. Employment decisions are based on qualifications, skills, experience, and business needs.
Frequently Asked Questions
Is the salary disclosed for the Senior Manager/Manager - Medical Review position at soterius?
The salary for this Senior Manager/Manager - Medical Review role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Senior Manager/Manager - Medical Review job at soterius remote?
Yes, this Senior Manager/Manager - Medical Review position at soterius is remote, with team members based in Navi Mumbai, MH, India, Noida, UP, India, Remote, Oregon, United States. You can work from home or anywhere in the supported regions.
Is the Senior Manager/Manager - Medical Review role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Manager/Manager - Medical Review role in the Manager, TL. Head department at soterius.
Which team or department does the Senior Manager/Manager - Medical Review at soterius belong to?
This Senior Manager/Manager - Medical Review position is part of the Manager, TL. Head department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Manager/Manager - Medical Review position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Senior Manager/Manager - Medical Review job at soterius posted?
This Senior Manager/Manager - Medical Review position at soterius was posted on Aug 19, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Manager/Manager - Medical Review
soterius
You'll be redirected to soterius's official application page on keka.