ICSR & Literature Procedure Management Professional
Location: Bengaluru, India
Job Category: Pharmacovigilance / Drug Safety
Job ID: [Insert ID]
Work Type: Full-time
Job Summary
Astellas is seeking a highly experienced ICSR & Literature Procedure Management Professional to support our Global Pharmacovigilance (PV) operations. This role ensures global consistency, compliance, and continuous improvement of ICSR (Individual Case Safety Reports) and Literature processes while managing global training programs. The position is based at Astellas Global Capability Centre, Bengaluru, India and reports to the Team Lead, Literature Management & Global Governance.
This role is ideal for professionals with extensive pharmacovigilance, regulatory affairs, quality assurance, or clinical development experience who are adept at process optimization, training management, and cross-functional collaboration.
Key Responsibilities
Process & Procedure Management
Maintain up-to-date ICSR & Literature global processes and procedures, ensuring alignment with industry best practices
Conduct continuous assessment of global procedures, identify gaps, and implement process improvements to enhance efficiency, effectiveness, and compliance
Manage planned and unplanned deviations, perform impact analysis, and oversee corrective actions
Lead process improvement initiatives, including cross-functional projects across global and regional teams
Ensure global inspection readiness of ICSR & Literature procedures
Collaborate with PV-Technology & Transformation and other stakeholders to implement system changes and procedural updates
Liaise with Medical Safety, Safety Science & Labelling teams to ensure process changes align with operational activities and regulatory requirements
Coordinate regulatory intelligence results and implement procedural updates globally
Training & Knowledge Management
Develop and oversee training programs for ICSR & Literature procedures
Maintain training matrix and coordinate delivery for RAPV Operations staff
Ensure PV awareness training content remains compliant with global AE (Adverse Event) collection standards
Provide guidance and mentorship for cross-functional teams on procedural compliance and best practices
Required Qualifications & Experience
Minimum MSc in Life Sciences
7+ years of relevant experience in pharmacovigilance, regulatory affairs, quality assurance, or clinical development
Demonstrated experience in governance roles and global procedure maintenance
Extensive knowledge of ICSR processing, literature management, and PV regulatory requirements
Proven ability to lead process improvement initiatives, preferably with Six Sigma or similar methodologies
Strong interpersonal, negotiation, and cross-cultural collaboration skills
Excellent written and verbal communication skills in English; experience interacting with all levels of personnel globally
Strategic thinker with ability to proactively resolve complex issues and implement solutions across functions
Strong analytical, decision-making, and leadership skills
Ability to independently manage projects spanning multiple functions
Working Environment
Astellas Global Capability Centres (GCCs) are strategically located to access global talent and co-locate core capabilities. Bengaluru GCC enhances operational efficiency, innovation, and responsiveness to business demands. GCCs play a critical role in delivering value to patients through operational excellence and sustainable growth.
Why Join Astellas?
Work within a globally recognized, innovative PV team
Opportunity to contribute to global patient safety and regulatory compliance initiatives
Engage in continuous learning and leadership development
Collaborative environment with multicultural teams and cross-functional exposure
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Important: Beware of recruitment scams. Authentic communication originates only from verified Astellas LinkedIn profiles or official company emails. Report suspicious activity to LinkedIn Help.
Apply Now
Qualified candidates will be evaluated by our recruitment team. Shortlisted candidates will be contacted with details on the next steps.
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
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Croatia |Zagreb :
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