Pharmacovigilance Product and Regulatory Associate

Job Description

Main Responsibilities The is a centralized role that is Responsible for collaborating with Country Safety heads (CSHs), Qualified Person for Pharmacovigilance (QPPV) office, SDEA, PV Case Medical Safety Manager, SSDM team to ensure that appropriate reporting rules (product, study, country) have been configured in the global PV DB. Responsible for overseeing PV labelling documents in Veeva Vault and ensure access to all parties involved. Responsible for providing support on getting labelling automated within PV Safety DB for all CHC products. Responsible for coordinating between countries and SSDM team for configuring distribution/ reporting rules. Responsible to follow QDs/ SOPs relevant to above mentioned activities. Responsible for review of the Weekly Veeva Flash report for newly registered CHC Products and configuration in the global PV database. Responsible for review of the Weekly Veeva Monitoring listing received for registration lifecycle updates for products globally and requesting the updates in global PV database CPD. Responsible for review of Vault RIM product updates and addition of new products for configuration in global PV database CPD. Responsible for maintaining mapping sheets of CHC products and truncated product lists with their respective names Responsible for review of the Regulatory Intelligence updates emails (CHC Global PV contact mailbox) from CSH/Affiliates, release communication to respective stakeholders and track the progress the required updates in global PV database as applicable. Responsible for implementation Annual product review and Annual distribution rules review with the help of CSH for all the countries and CHC products in global PV database as per the established SOPs. Other PV tasks as required. This role is responsible for ensuring product configurations, distribution rules configurations and maintain of CPD. This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the constantly changing PV Regulations and ensuring that we follow them Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. 3-4 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in product configurations, reporting rule configurations. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Good knowledge SDEA agreements Strong experience in product dictionaries and database reporting rule configurations Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 3-4 years’ experience in Global PV database and/or PV case Management Languages : Fluent in English (verbal and written) Show more Show less