Prepare Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Periodic Adverse Drug Experience Reports (PADERs) for regulatory submissions.
Conduct literature reviews and maintain awareness of safety issues regarding Apotex products.
Draft responses to complex safety information queries for internal stakeholders such as Regulatory Affairs (RA), Quality Assurance (QA), and New Product Development (NPD) teams.
Develop and maintain Standard Operating Procedures (SOPs) and training documents for global drug safety reporting.
Utilize software tools like Oracle ARGUS and apply MedDRA terminology.
Ensure compliance with ICH guidelines, safety regulations, and company policies.
Additional Contributions:
Collaborate with internal departments and global partners to improve pharmacovigilance processes.
Provide feedback for process improvement initiatives and maintain strong working relationships with external partners and affiliates.
Stay updated on pharmacovigilance regulations and contribute to team knowledge enhancement.
Candidate Profile
Qualifications: B.Pharm, Pharm.D, M.Pharm, or a degree in Nursing or related health science disciplines.
Experience:
At least 1-2 years of pharmaceutical industry experience in pharmacovigilance.
Preferred experience in periodic safety reviews and aggregate safety data analysis.
Skills:
Strong knowledge of MedDRA, Oracle ARGUS, and online literature search tools.
Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
Excellent analytical, problem-solving, and communication skills.
Familiarity with local and international safety regulations and ICH guidelines.
