Development and implementation of Standard Operating Procedures (SOPs).
Review and Perform signal management activity as per guideline and SOP.
Preparation, review and reporting of aggregate reports (Such as PADER, PBRER and PSUR) as per regulatory requirement with compliance to guideline and SOP.
Oversight of in-house and out-sourced PV activities and maintain monthly compliance process.
Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports, Signal management and all EU activities.
Facilitate safety monitoring by optimizing scientific quality documentation and data entry of safety case reports including spontaneous litigation reports.
Management of ICSR activities as per respective regulatory requirement, including safety data accuracy in safety database.
Training management of PV team and other stakeholder timely manner for regulatory requirement and safety awareness.
Responsible for partner/vendor audit and communication for all PV activity.
Preparation and review of SDEA.
Handling of RMP program in line with innovator for UK & EMA.
Manage a team of pharmacovigilance professionals, providing guidance and ensuring efficient workflow.
Interface with regulatory authorities, healthcare professionals, and internal stakeholders to communicate safety information.
Management of XEVMPD & SPOR database with timely update safety variation in line with Art. 57 guideline.
Candidate Qualification
B.Pharm/ M.Pharm (Pharmacology)
Candidate Requirements
9 to 12 Years of experience in PV domain or drug safety, with at least 2 years in a managerial or supervisory role.
Experience in regulatory reporting, adverse event management, risk management, and signal detection.
Knowledge of pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
Skills and Competencies
Strong leadership and management skills.
Excellent communication skills, both written and verbal.
Analytical and problem-solving skills.
Attention to detail and accuracy.
Ability to work effectively in a cross-functional team environment.
Proficiency in pharmacovigilance databases and software (e.g., ARGUS, ARISg).
