Job Description
● 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.
Requirements
● 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.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Educations
Seniority
