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Drug Safety Professional and Registered Pharmacist with 10 years of experience in all aspects of project management, ICSR case processing, assessing safety data, reporting and submissions, authoring aggregate reports for assigned products, performing signal management process and document management in Veeva. Expertise in MedDRA coding, expedited reporting and remarkable knowledge of US and ICH safety reporting regulations and guidelines. Providing root cause analysis (RCA) and implemented CAPA for authority. Local pharmacovigilance monitoring and perform impact assessments for regulatory documents. Experience in leading cross-functional teams and taking initiative to understand assignments. Core team member in PV automation (ArisG to LSMV, E2B R3 implementation) to meet regulatory requirements and strengthen drug safety. Signal Management (end-to-end) and performing Benefit-Risk Analysis and UAT testing. Experience in health authority inspections/internal audits and served as PV regulatory SME.

With extensive experience in pharmacovigilance operations, clinical research, and medical writing both in academia and at a CRO, I am a highly skilled professional delivering exceptional services that exceed industry standards.

Enthusiastic, dedicated Pharmacovigilance expert with One and half years of experience in Clinical and Pharmacovigilance, including Case processing, booking, data entry, MedDRA and Narrative Writing.
Medical Evaluation of ICSR, Aggregate Reports, Signal Detection, and Risk Management. Analysis, Risk Evaluation, Mitigation Strategies, and medical assessment/ evaluation as well.
Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Trained & Certified with a Clear understanding of Pharmacovigilance and Clinical trials.
Motivated to learn, grow and excel in the field. Critical thinker with a background in developing and improving methodologies and procedures for superior data analysis and reporting.

Dynamic pharmacovigilance professional with 10 years of experience in global pharmacovigilance (PV), clinical safety, and case management. Proven expertise in PV regulations, global compliance, and technological solutions across multiple PV functional areas. Adept at leading cross-functional collaborations, optimizing safety systems, and driving automation to enhance operational efficiency. Strong leadership, analytical, and problem-solving skills with a track record of ensuring regulatory compliance and patient safety in high-pressure environments.

Md Tabrez Alam

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Pharmacist (Drug Safety Exposure)

Pharmacist

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Bachelor of Pharmacy (B.Pharm) - Pharmacy

Intermediate Certificate - Science

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Pharmacist (Drug Safety Exposure)

Pharmacist

Bachelor of Pharmacy (B.Pharm) - Pharmacy

Intermediate Certificate - Science

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