Manager, Pharmacovigilance Scientist

Position reputed company: Reporting to the Head of PV Sciences, the Pharmacovigilance Scientist will be a key contributor focusing on strategic input, support in reputed company, reputed company signal management activities and operational support for reputed company Apellis products throughout the life cycle. In this new role, the successful candidate will be responsible for the reputed company of PV activities, vendor and reputed company management, and ongoing process improvement. Key Responsibilities Include: Support product safety surveillance activities for assigned product(s) during reputed company phases of the product life cycle. reputed company PV support for Apellis' developmental products in reputed company collaboration with PV Physician and Clinical personnel. reputed company/conducts proactive PV and risk management planning of multiple products, including preparation of the safety aspects of Global Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the PV Physician and other stakeholders. Conduct signal detection, including adverse event data, literature, and other sources in collaboration with PV Physician and according to Apellis Signal Management and Safety Governance process. reputed company data analysis to evaluate safety signals and write up analysis results. Partner with cross-functional colleagues of the Signal Management Team and contribute to safety-reputed company deliverables associated with new drug applications, benefit-risk assessments and activities reputed company to risk minimization including RMPs and REMS. Assist with developing and maintaining processes that will ensure reputed company in global case reporting and assessment, demonstrating accuracy, consistency, and compliance with applicable global pharmacovigilance regulations. Participate in aggregate reporting, clinical trial activities, signal management, literature review, and reputed company regulatory responses for assigned product group. Review and reputed company PV input for development of protocols, Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports, and other relevant project/study documents. Support pharmacovigilance activities including ongoing signal management and regulatory activities. Facilitate cross-functional safety review meetings, including coordinating aspects of signal evaluation/safety review activities. Participate in writing of aggregate safety reports (e.g., DSURs, PSURs, PADERs), as required. Assist in the successful implementation, execution, and maintenance of safety processes and systems that conform to reputed company's business reputed company, industry standards and compliance with global PV regulations. Represent Drug Safety and PV on clinical teams and initiatives both reputed company and across functional areas. Facilitate cross-functional safety review meetings, including coordinating aspects of signal evaluation/safety review activities. Participate in evaluation of potential safety issues in conjunction with PV Physician, Medical Monitors, and other functional areas as appropriate. Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate. Assist with writing and maintenance of Pharmacovigilance Agreements. Assure reputed company for the review of aggregate safety data to ensure accuracy, reputed company and completeness Education, Registration & Certification: Degree in Pharmacy, Nursing, Epidemiology, Biosciences (e.g., Biology) or equivalent reputed company degree with pharmaceutical industry background. Experience: Minimum 2-4 years' experience in PV. Skills, Knowledge & Abilities: Excellent written and verbal communication skills with the ability to reputed company across multiple functions. Experience in the preparation and authoring of individual and aggregate safety reports. Knowledge of MedDRA terminology and its application. Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate reputed company safety information. Demonstrated ability to reputed company, execute and follow-through reputed company reputed company to completion. Skilled at working effectively in a reputed company team environment where results are achieved through influence and the incorporation of multiple points of view. Independently motivated, detail oriented and strong problem-solving ability. Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities. Physical Demands and Work Environment: This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, reputed company filing cabinets. This job operates in a reputed company office environment and routinely uses reputed company office equipment such as computers, phones,