Medical Assurance Professional
Job ID: #PJT00274
Location: Bengaluru, India
About Astellas
Astellas Pharma Inc. is a leading global pharmaceutical company operating in more than 70 countries worldwide. We are dedicated to turning innovative science into medical solutions that deliver value and hope to patients and their families. Our focus on ethics, integrity, and patient-centric innovation drives every aspect of our work.
🌐 Visit: www.astellas.com
Astellas Global Capability Centres (GCCs)
Our GCCs—located in India, Poland, and Mexico—enable Astellas to access global talent and co-locate key functions to enhance operational efficiency, innovation, and resilience.
These centres are core enablers of Astellas’ strategic priorities, sustainable growth, and commitment to creating VALUE for patients.
Purpose and Scope
The Medical Assurance Professional supports the Medical Assurance function within Pharmacovigilance (PV) and Regulatory Affairs Pharmacovigilance (RAPV) Operations.
This role contributes to ensuring high medico-scientific quality and consistency in Individual Case Safety Reports (ICSRs) to effectively manage the safety profile of Astellas’ marketed and investigational products.
The position involves collaboration with vendor medical teams, Astellas PV colleagues, and cross-functional stakeholders to maintain and improve medical assessment quality, systems, and processes.
Key Responsibilities
1. Operational Oversight
Oversee the daily management of the Medical Assurance mailbox, including triaging, direct handling, and distribution of urgent and routine medico-scientific requests.
Manage correspondence related to potential safety issues, reference safety information (RSI) updates, product trainings, and ICSR-related inquiries.
2. Process Improvement & Quality
Lead or contribute to global cross-functional initiatives and process improvements impacting medico-scientific aspects of ICSR reporting.
Participate in cross-functional teams to represent the medical voice of RAPV Operations.
Support non-conformance investigations, CAPAs, and quality improvement initiatives related to medical review activities.
3. Medical Tools & Systems Management
Ensure maintenance and optimization of PV Case Management medical support tools, including RSI, Medical Concept Library, and Expected Preferred Terms Lists (EPTLs).
Lead medico-scientific activities for biannual MedDRA updates.
Perform Medical Assurance activities supporting maintenance of product labelling and Reference Safety Information (RSI) for marketed and investigational products.
4. Training & Collaboration
Deliver training and medical education sessions for internal teams and vendor medical personnel on medico-scientific ICSR processes.
Collaborate with RAPV and non-RAPV functions to ensure consistency and compliance in ICSR assessment activities.
Support inspection readiness and audit preparation for medico-scientific topics.
5. Documentation & Compliance
Maintain quality documents owned by Medical Assurance, ensuring compliance with global standards.
Conduct impact assessments for non-conformances affecting ICSR case processing.
Ensure regulatory documentation and support tools are current, validated, and audit-ready.
Required Qualifications
Education:
Minimum BSc degree in Life Sciences or equivalent.
Experience:
At least 5 years of relevant experience in Pharmacovigilance, Regulatory Affairs, Quality Assurance, or Clinical Development.
Minimum 2 years of case processing experience (post-marketing or clinical trial), including seriousness, expectedness, and causality assessments.
Strong understanding of safety regulations for marketed and investigational products.
Technical Expertise:
Proficient in MedDRA dictionary coding.
Deep knowledge of global regulatory frameworks (ICH, CFR 21, FDAAA, EU GVP, JP regulations).
Skilled in process improvement and quality management.
Ability to solve complex problems using creative and compliant approaches.
Preferred Qualifications
Medical/Physician qualification (e.g., MBBS, MD, PharmD).
Advanced Excel proficiency, including formula and macro development.
Key Competencies
Strong analytical and critical-thinking skills.
Excellent communication and cross-functional collaboration abilities.
Detail-oriented, proactive, and quality-driven mindset.
Ability to manage multiple priorities in a global, matrixed environment.
Why Join Astellas
Work with a global leader in life sciences and patient safety.
Collaborate in a diverse, inclusive, and innovation-driven environment.
Contribute directly to medical and regulatory excellence.
Drive continuous improvement across PV systems and quality frameworks.
Location: Bengaluru, India
Job ID: #PJT00274
Apply Now: Astellas Careers – Apply Here
⚠️ Important Notice:
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. Report any suspicious activity to LinkedIn Help.
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