Pharmacovigilance Services Associate Manager

Role Overview You will lead pharmacovigilance services by conducting comprehensive medical reviews of aggregate and Risk Management Plan reports within agreed timeframes and to high standards of accuracy. This role involves ensuring compliance with client standard operating procedures and global regulatory requirements while managing the detection, assessment, and prevention of adverse effects related to pharmaceutical products. You will be responsible for analyzing safety data to identify potential risks and protect patient health while supporting pharmaceutical companies in meeting regulatory obligations. Key Responsibilities - Conduct medical review of aggregate and RMP reports ensuring they are medically relevant, complete, consistent and accurate in compliance with client SOPs and global regulatory requirements - Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for clinical study reports - Address all previous Health Authority comments and ad-hoc requests received from regulatory bodies - Review noteworthy cases and published studies including pregnancy registries and provide medical analysis for all relevant sections of aggregate reports and RMP - Perform quality control of all assigned aggregate reports and RMP documents and notify critical and major deviations within one business day - Participate in Key Opinion Manager meetings, project planning and strategy making sessions and provide coaching and feedback to mentees Required Qualifications - MBBS or MD degree with 10 to 14 years of experience in pharmacovigilance safety writing and medical review - Expert level ability in English language with demonstrated experience in medical review of aggregate and RMP reports - Knowledge of quality management, compliance, and healthcare pharmaceutical processes Why Join Us Accenture offers opportunities to work on global pharmacovigilance projects while developing expertise in medical safety and regulatory compliance. You will contribute to ensuring medication safety and efficacy while maintaining public trust in pharmaceutical products.

- MBBS or MD qualification - 10 to 14 years experience in pharmacovigilance and safety writing - Medical review experience with aggregate reports and RMP - Expert English language proficiency - Knowledge of quality management and compliance - Experience in coaching and knowledge sharing - Understanding of clinical trials and healthcare regulatory requirements - Proficiency with Learning Management Systems - Project planning and strategy development experience

- Full time permanent employment - Exposure to global pharmaceutical and regulatory standards - Opportunity for knowledge sharing and team coaching - Professional development through assigned trainings - Compliance with international healthcare and safety standards