Executive (Pharmacovigilance), SMD

Healthcare Pharmaceuticals Ltd. (HPL) is one of the leading pharmaceutical companies in Bangladesh, committed to maintaining high standards of quality and patient safety. The company holds certifications and approvals from several international pharmaceutical regulatory authorities, including EU GMP, TGA (Australia), NPRA (Malaysia), MCAZ (Zimbabwe), and TFDA (Tanzania).

HPL places strong emphasis on patient safety and pharmacovigilance, focusing on identifying, evaluating, and minimizing potential safety risks associated with its pharmaceutical products. The company is seeking motivated professionals to join its team and contribute to its commitment to quality healthcare and public safety.

Job function: Pharmacovigilance

Location: Head Office

Responsibilities & Context

• Ensure timely reporting, documentation, and follow-up of Adverse Events (AEs) and Product Complaints (PCs) in compliance with HPL SOPs, Good Pharmacovigilance Practices (GVP), and DGDA requirements.

• Identify, investigate, document, and escalate pharmacovigilance and quality compliance issues.

• Implement and monitor Corrective and Preventive Actions (CAPA) to address identified compliance and quality gaps.

• Prepare, review, update, implement, and provide training on Pharmacovigilance SOPs, guidelines, and regulatory requirements.

• Conduct quarterly Quality Control (QC) of Individual Case Safety Reports (ICSRs), PSURs, and RMPs within the HPL Safety Database.

• Prepare detailed QC reports and ensure proper documentation of quality review activities.

• Coordinate and support pharmacovigilance audits of external partners and assist with related compliance activities.

• Perform other pharmacovigilance and quality-related responsibilities assigned by management.