Alcon Pharmacovigilance Vacancy: Patient Safety Specialist

Alcon Hiring Patient Safety Specialist

About Alcon

Alcon, a renowned global leader in eye care, is currently seeking qualified professionals for the role of Patient Safety Specialist. With a commitment to innovation and patient well-being, Alcon offers a dynamic work environment and ample opportunities for career growth.

Company Vacancies List

• Position Title: Patient Safety Specialist
• Company Name: Alcon

Job Description

Role: Patient Safety Specialist

Industry Type: Healthcare
Department: Pharmacovigilance
Employment Type: Full Time
Role Category: Compliance, Quality Assurance, Regulatory Affairs
Educational Background Required: Bachelor’s degree (healthcare, science emphasis preferred)
Key Skills: Pharmacovigilance, Compliance, Quality Assurance, Regulatory Affairs

Key Responsibilities:

1. To support management of operational processes in ensuring compliance with Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
2. Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
3. Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
4. Work with other local/global PV associates to ensure accurate evaluation of safety data.
5. Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
6. Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
7. Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
8. Management and maintenance all relevant assigned PVO databases, if applicable.
9. Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
10. Provide timely, relevant information to trial coordinators, CRAs and other Sandoz staff -Distribution of marketing samples (where applicable)

Key Requirements/Minimum Qualifications:

• Meet internal and external quality standards for complaint records management.
• 3-5 years clinical experience (optometric office preferred).
• 1-3 years relevant work experience in device/drug safety, compliance, quality assurance, regulatory affairs.
• Work hours: 7 PM to 4 AM or 9 PM to 6 AM IST

Skills:

• Databases.
• Employee Training.
• Filing (Documents).
• Pharmacovigilance.
• Reporting.
• Safety Science.

Additional Information:

• Relocation Assistance: Yes
• Equal Opportunity Employer: Alcon is committed to maintaining a diverse environment.

Apply online

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers