01 Oct
|
European pharmaceutical
|
Bengaluru
01 Oct
European pharmaceutical
Bengaluru
Key Responsibilities
- Provide therapeutic area expertise, including unmet medical needs, standards of care, treatment trends, treatment guidelines, etc., related to the organization's products for various internal stakeholders.
- Maintain the Medical Information System (IRMS – Information Request Management System) for the organization's products, ensuring that medical information is accurate, balanced, timely, compliant, and of high quality for both internal and external stakeholders.
- Provide medical expertise to support existing products, particularly with respect to their safety profiles, including Health Hazard Evaluation (HHE) and medical assessments related to quality deviations.
- Support medical writing and/or review of clinical sections of regulatory submission documents, including Common Technical Dossiers (CTDs), Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), clinical overviews, and summaries.
- Prepare scientific responses and justifications on medical and clinical matters.
- Provide independent medical support to the Marketing, Commercial, and Portfolio teams by strengthening cross-functional collaboration and contributing medical expertise to promotional and educational materials for internal and external stakeholders.
- Prepare, maintain, and periodically update medical information related to the organization's commercial product portfolio.
- Provide scientific support to cross-functional teams, including R&D;, MS&T;, MQA, and CQA, contributing to informed scientific and quality-related decisions.
- Develop expertise in toxicology to support the organization's future business and scientific needs.
- Ensure compliance with all applicable laws, regulations, and ethical standards related to Medical Affairs and Pharmacovigilance Operations.
- Perform all activities in accordance with applicable legislation, guidelines, standard operating procedures, and company policies.
- Demonstrate the organization's behavioral values and professional standards at all times.
The organization is committed to developing and supplying critical anti-infective therapies for serious and life-threatening infections. It strives to be a global leader in delivering innovative anti-infective solutions that address unmet patient needs and expand available treatment options.
As a pharmaceutical organization operating in a highly regulated environment, an understanding of financial reporting and decision-making within regulated industries is advantageous, though not mandatory.
Reporting Structure
- The role is part of the Quality function and reports to the Senior Manager – Medical Affairs & Pharmacovigilance Operations, based in Bengaluru.
Key Stakeholders
- Executive Leadership Team
- Functional Managers
- Business Leadership Team
- Cross-functional Business Stakeholders
Candidate Profile
Qualifications
Education
- Master's degree (or equivalent) or Ph.D. in a relevant scientific discipline.
Experience
- Minimum 5 years of relevant experience in the pharmaceutical industry, preferably in R&D;, Clinical Pharmacology, Medical Affairs, or Pharmacovigilance.
- Robust ability to interpret and derive insights from scientific literature.
- Excellent communication and stakeholder management skills in a global environment.
- Strong analytical thinking, attention to detail, and the ability to work independently.
- Demonstrated application of scientific principles to problem-solving and interpretation of scientific data.
- Proven ability to work collaboratively in cross-functional teams.
- Ability to manage multiple priorities in a fast-paced environment.
Compensation & Benefits
Compensation
- Annual Fixed Compensation
- Variable Pay: 10% of Annual Fixed Compensation
Retirement Benefits
- Provident Fund
- Gratuity
Insurance & Other Benefits
- Group Medical Insurance: ₹5 Lakhs (Employee + up to 7 dependents)
- Personal Accident Insurance: ₹25 Lakhs (Employee only)
- Group Term Life Insurance: Minimum ₹50 Lakhs (Employee only)
- Internet Expense Reimbursement: Up to ₹1,500 per month
📌 Senior Medical Information Specialist I (Bengaluru)
🏢 European pharmaceutical
📍 Bengaluru