Background information about the job or company (e.g., role context, company overview)

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Our portfolio includes over 1000 products across wide range of therapeutic categories ...

Responsibilities or duties

Establish and maintain a single-point system for collecting/collating all suspected adverse reaction reports (including from medical reps and CRAs)

Collect, evaluate, process, and submit Individual Case Safety Reports (ICSRs)

Prepare and submit Periodic Safety Update Reports (PSURs) as needed

Manage Risk Management Plans (RMPs)

Negotiate, implement, and maintain Safety Data Exchange Agreements (SDEAs)

Implement and maintain the Drug Safety System Database and Master Files, including data reconciliation (including with 3rd parties)

Conduct required literature searches

Respond to Health Authority safety queries on Company products

Contribute to Annual Product Quality Reviews (APQRs)

Train Company employees on drug safety procedures

Ensure compliance with jurisdiction-specific drug safety legislation

Ensure consistency of drug safety processes/procedures and staff training

External Stakeholder Relationship Management

Build and manage relationships with business partners, complying with PVA/SDEA requirements

Build relationships with Cipla Global and align with Global Drug Safety

Maintain a strong profile with regulatory authorities and industry bodies to positively influence company perception

Cross-Functional Alignment

Determine how the function can best serve the business

Measure stakeholder satisfaction/performance and identify improvements

Ensure adherence to SLAs and performance criteria

People Management

Hire appropriately skilled personnel in line with transformation objectives; maintain competence records and organograms

Provide and assess training for the DS team

Ensure PV induction training for new SSA employees

Keep DS team Job Descriptions current (annual review or on scope change)

Set SMART objectives for DNA (performance) purposes

Support ongoing training and career development

Manage DS team performance (with VP: Head of Quality)

Ensure HR policy adherence within the team

Qualifications or requirements (e.g., education, skills)

BA/BSc/HND

Experience needed

Not specified

Any other provided details (e.g., benefits, work environment, team info, or additional notes)

Never pay for any notarisation, certificate or assessment as part of any recruitment process. When in doubt, contact us

• Establish and maintain a single-point system for collecting/collating all suspected adverse reaction reports (including from medical reps and CRAs)
• Collect, evaluate, process, and submit Individual Case Safety Reports (ICSRs)
• Prepare and submit Periodic Safety Update Reports (PSURs) as needed
• Manage Risk Management Plans (RMPs)
• Negotiate, implement, and maintain Safety Data Exchange Agreements (SDEAs)
• Implement and maintain the Drug Safety System Database and Master Files, including data reconciliation (including with 3rd parties)
• Conduct required literature searches
• Respond to Health Authority safety queries on Company products
• Contribute to Annual Product Quality Reviews (APQRs)
• Train Company employees on drug safety procedures
• Ensure compliance with jurisdiction-specific drug safety legislation
• Ensure consistency of drug safety processes/procedures and staff training
• Build and manage relationships with business partners, complying with PVA/SDEA requirements
• Build relationships with Cipla Global and align with Global Drug Safety
• Maintain a strong profile with regulatory authorities and industry bodies to positively influence company perception
• Determine how the function can best serve the business
• Measure stakeholder satisfaction/performance and identify improvements
• Ensure adherence to SLAs and performance criteria
• Hire appropriately skilled personnel in line with transformation objectives; maintain competence records and organograms
• Provide and assess training for the DS team
• Ensure PV induction training for new SSA employees
• Keep DS team Job Descriptions current (annual review or on scope change)
• Set SMART objectives for DNA (performance) purposes
• Support ongoing training and career development
• Manage DS team performance (with VP: Head of Quality)
• Ensure HR policy adherence within the team

• BA/BSc/HND