Medical Reviewer Job at EVERSANA
Ready to lead pharmacovigilance and medical review activities for global pharmaceutical products? EVERSANA is hiring a Lead Medical Reviewer to support product surveillance, risk management, and regulatory safety activities across global client projects. This Medical Reviewer Job at EVERSANA is ideal for experienced pharmacovigilance professionals with a strong medical background and expertise in aggregate reporting, signal detection, and benefit-risk evaluation. If you’re looking to lead high-impact drug safety initiatives while working with a global life sciences organization, this role offers an excellent career path.
About the Company:
EVERSANA is a leading global life sciences company that provides integrated commercialization services to the pharmaceutical, biotechnology, and medical device industries. With expertise spanning clinical development, pharmacovigilance, regulatory affairs, market access, medical affairs, and commercialization, EVERSANA helps bring innovative therapies to patients worldwide while improving healthcare outcomes through technology-driven solutions.
Job Details:
- Position: Lead Medical Reviewer
- Location: India
- Department: Pharmacovigilance / Medical Review
- Employment Type: Full-time
Key Responsibilities:
- Support the timely and compliant execution of product surveillance activities for client projects.
- Oversee and contribute to aggregate reports, including PADERs, PBRERs, Risk Management Plans (RMPs), PLLR, and annual literature reviews.
- Serve as the Subject Matter Expert (SME) for medical review and Individual Case Safety Report (ICSR) management in this Medical Reviewer Job in India.
- Develop materials for Safety Management Team (SMT), Pharmacovigilance Committee (PVC), and Safety Data Review meetings.
- Lead signal management, signal detection, and benefit-risk evaluation activities.
- Provide medical and pharmacovigilance leadership during safety governance meetings.
- Oversee operational execution of safety-related clinical trial activities at EVERSANA.
- Support the authoring of integrated regulatory submission documents.
- Provide medical expertise for clinical protocol development and medical monitoring of clinical trials.
- Prepare safety sections for protocols, informed consent forms, Investigator’s Brochures, DSURs, PSURs, Annual Reports, Company Core Data Sheets, and Risk Management Plans.
- Supervise study-level pharmacovigilance activities, including ICSR generation, Clinical Study Reports, protocol reviews, and risk-benefit assessments.
- Train, mentor, and supervise junior safety scientists and pharmacovigilance staff.
- Lead pharmacovigilance process improvement and quality assurance initiatives.
- Provide strategic pharmacovigilance guidance and medical writing support.
- Contribute to business development activities as required.
- Promote diversity, equity, and inclusion within the workplace.
Educational Requirements for the Medical Reviewer Job:
- MD or MBBS from a recognized institution.
- Board-certified Physician with at least 2 years of clinical experience.
- Minimum 7 years of pharmacovigilance experience.
- Experience in pharmaceutical or biotechnology drug development.
- Expertise in preparing Risk Management Plans, aggregate safety reports, and company core safety information.
Skills Required:
- Strong knowledge of global pharmacovigilance regulations and safety reporting requirements.
- Expertise in signal detection, benefit-risk evaluation, and product surveillance.
- Experience with PADERs, PBRERs, PSURs, DSURs, RMPs, PLLR, and ICSRs.
- Strong medical review and safety data analysis skills.
- Clinical trial safety monitoring experience.
- Medical writing and regulatory documentation expertise.
- Leadership, mentoring, and people management skills.
- Excellent analytical and problem-solving abilities.
- Strong organizational and interpersonal skills.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint.
- Ability to work proactively in a fast-paced, cross-functional environment.
Benefits of the Medical Reviewer Job:
- Opportunity to lead global pharmacovigilance and medical review projects.
- Work with an internationally recognized life sciences organization.
- Exposure to advanced drug safety, regulatory, and risk management activities.
- Opportunity to collaborate with multidisciplinary global teams.
- Leadership role with mentoring and career development opportunities.
- Involvement in strategic pharmacovigilance initiatives and process improvements.
- Dynamic and inclusive workplace that values diversity, equity, and innovation.
- Opportunity to contribute to the safe development and commercialization of innovative therapies worldwide.
