Job Title: Medical Safety Expert
Company: Novartis
Location: India
Salary: ₹6.0 Lakhs to ₹11.1 Lakhs per annum
Qualifications: B.Pharm, B.Sc, Pharm.D, Ph.D, MBBS, MD
Experience: Minimum 2 years
Job Description:
As a Medical Safety Expert at Novartis, you will play a crucial role in the Patient Safety & Pharmacovigilance department. You will support medical safety management, including the review and assessment of Individual Case Safety Reports (ICSRs), aggregate reports, and co-authoring safety documents. Your responsibilities will encompass providing safety input to regulatory and clinical documents, as well as handling ad-hoc Health Authority queries. You will ensure compliance with patient safety business rules, standard operating procedures, and global regulatory requirements.
Key Responsibilities:
- Co-authoring Safety Documents: Collaborate on the creation of safety documents and provide expertise in regulatory and clinical safety requirements.
- Medical Review of ICSRs: Evaluate Individual Case Safety Reports, including cases from special countries and literature cases, ensuring thorough medical assessments.
- Literature Review and Assessment: Conduct systematic reviews of assigned articles and assist in reviewing articles for inclusion in periodic regulatory reports such as PBRER (Periodic Benefit-Risk Evaluation Report) and DSUR (Development Safety Update Report).
- Safety Input and Support: Assist in preparing medical assessment letters and enhanced Minimal Assessment Criteria (MAC), contributing to bi-annual line listings.
- Therapeutic Area Support: Provide rotating support to various Therapeutic Areas (TAs) as per business needs, assisting in safety document co-authoring and regulatory input.
- Product Safety Monitoring: Collaborate with TA Safety Leads to monitor product safety profiles, conduct medical reviews of individual cases, collect follow-up information, and evaluate quality defects.
- Regulatory Documentation: Co-author sections of regulatory documents such as PBRER, DSUR, Investigator Brochures (IB), labeling documents (CDS, SMPC, USPI, Japanese PI), and Product Guidance Documents (PGD).
- Signal Detection and Evaluation: Support signal detection and evaluation activities for assigned products, contributing to clinical and safety overview processes.
- Training and Development: Develop and optimize training materials, delivering training sessions to Novartis staff and external stakeholders to enhance understanding of pharmacovigilance practices.
- Quality and Compliance: Maintain a high standard of accuracy and compliance with global and local regulatory requirements, participating in internal review meetings and supporting audits and inspections as a Subject Matter Expert (SME).
- Cross-Functional Collaboration: Collaborate with other Global Line Functions within Novartis and third parties to achieve joint pharmacovigilance accountabilities and contribute to cross-functional projects.
- Process Optimization: Contribute to Pharmacovigilance (PV) initiatives aimed at optimizing medical review processes, developing metrics, standards, and tools to monitor PV system performance effectively.
Qualifications and Skills:
- Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences (B.Sc), Medicine (MBBS, MD), or related fields. Advanced degrees such as Pharm.D or Ph.D are preferred.
- Minimum of 2 years of experience in medical safety, pharmacovigilance, or related fields within the pharmaceutical industry.
- Strong understanding of global pharmacovigilance regulations and guidelines (ICH, FDA, EMA, etc.).
- Excellent analytical, communication, and collaboration skills with the ability to work effectively in a cross-functional team environment.
- Proven ability to deliver high-quality work under tight deadlines, adhering to standard operating procedures and regulatory requirements.
Additional Information:
- This position offers a competitive salary and benefits package reflective of the pharmaceutical industry standards.
- Join a dynamic team at Novartis dedicated to advancing global healthcare through impactful pharmacovigilance practices.