● Process and report adverse reactions received from healthcare professionals and consumers.
● Conduct in-depth interviews with patients and healthcare professionals.
● Conduct follow-up calls and prepare written communications to obtain follow-up information.
● Write accurate and complete narratives in accordance with internal guidelines and SOP’s.
● Coordinate review and approval of key PV deliverables, such as PSMF updates, periodic safety update reports (PSURs), risk management plans, etc.
● Flagging up early warning signs of adverse effects of drugs.
● Complete safety audits.
● Support clinical trial safety data management and review/approval of safety management plan.
● Represent PV Operations function during regulatory PV inspections.
● Assist in the development and maintenance of corporate policies and procedures, training material, and PV training rollout.
● Provide relevant PV Training as needed across the global organization.
● PharmD, MD, or related sciences fields.
● At least 2 years of experience in relevant fields.
● Strong knowledge of Drug Safety and Pharmacovigilance processes and regulations.
● Working knowledge of MedDRA and WHO Drug coding principles and practical applications.
● Working knowledge of relevant FDA, EU, ICH guidelines, initiatives, and regulations governing safety reporting and processing for clinical trial and marketed product environments.
● Strong ability to effectively collaborate with cross-functional team members in a matrix organization, with excellent organizational skills, interpersonal skills, and conflict management capability.
● Fluency in English.
● Proficiency in the use of Windows and MS Office and ability to learn new systems as needed.
● Strong analytical and problem-solving skills.
● Excellent written and oral communication skills to interact with internal and external stakeholders as needed.
● Age range: under 35 is preferred.