Mohammed Rafiq
Dubai,DU
Summary
Detail-oriented Pharmacovigilance professional with 2+ years of hands-on experience in processing adverse event reports, patient narrative writing, and MedDRA coding. Demonstrated expertise in expedited case processing, data entry, and regulatory submissions. Proven ability to work within SOPs and global compliance frameworks. Seeking to leverage my skills in a Clinical Safety Associate role to support clinical trial and post-marketing safety operations.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Senior Process Executive
Cognizant
12.2022 - 09.2023
- Processed spontaneous and clinical trial adverse event reports within defined timelines.
- Performed MedDRA coding and authored clear patient narratives for global submissions.
- Conducted listedness assessments and supported database reconciliation activities.
- Participated in the preparation and dispatch of expedited reports to clients and authorities.
- Ensured adherence to SOPs and quality frameworks during case intake, processing, and submissions.
Process Executive
Cognizant
11.2021 - 12.2022
- Triaged incoming safety information and ensured accurate data entry into safety tracking systems.
- Collaborated with cross-functional teams for query resolution and missing information collection.
- Supported compliance documentation and archival procedures per regulatory expectations.
Education
Bachelor of Pharmacy - B.Pharm
AIKTC
01.2021
Skills
- Management of serious and non-serious AE documentation
- Regulatory reporting expertise
- Database management: MedDRA and WHO-DD
- Knowledge of ICH-GCP and regulatory guidelines
- Standard operating procedure compliance
- Effective communicator in diverse settings
- Proficient in documentation management
- Detail-oriented accuracy
- Collaborative initiative
- Strong prioritization skills
Certification
- Health Research Fundamentals (ICMR-NPTEL, Ministry of HRD, Govt. of India)
- Licensed Pharmacist (India)
Languages
English (Fluent)
Hindi (Fluent)
Tamil (Fluent)
Additional Information
- Available to relocate or work remotely.
- Open to roles in Clinical & Drug Safety Specialist ,Adverse Event Case Processor, Patient Safety Coordinator,Pharmacovigilance, or regulatory operations, Quality & Compliance Officer in Healthcare Facilities.
Timeline
Senior Process Executive
Cognizant
12.2022 - 09.2023
Process Executive
Cognizant
11.2021 - 12.2022
Bachelor of Pharmacy - B.Pharm
AIKTC
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