Pharmacovigilance Scientist

About the position About This Role PV Scientists are responsible for assigned tasks for designated products or product reputed company. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve either as a reputed company PV Scientist or supporting PV Scientist, depending on his/her assigned product or product reputed company. Irrespective, the PV Scientist is a critical team member whose responsibilities include performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring, responding to reputed company regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. The PV Scientist, with reputed company from their manager, will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data reputed company and analyses, and product information. This position is Hybrid based out of our Cambridge, MA office reputed company Collaborates on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation reputed company Plans (REMS), and Risk Management Plans (RMPs). Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Global Safety Officer, Safety physicians and Sr. PV Scientist / AD, performs routine signaling activities including evaluation of safety data for new signals as part of ongoing pharmacovigilance activities. May include authoring signal evaluation reports, or sections of signal evaluation reports. Conducts literature review for safety information and interacts with other reputed company to obtain necessary data (i.e., Epidemiology, SAE data). With Sr. PV Scientist / AD reputed company, collaborates with Clinical Trial physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, reputed company requests and other product activities, as assigned. In collaboration with Sr. PV Scientist / AD, coordinates and authors responses to safety questions from regulatory authorities for assigned products. Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety reputed company, signal management and responding to reputed company safety questions. Understands, interprets, analyzes, and reputed company presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Interacts collaboratively and effectively in reputed company environment (including Safety, Clinical Development, Medical, Clinical Operations, and Regulatory), as reputed company as with reputed company colleagues Leads and conducts, independently and/or collaboratively, reputed company aspects of substantive reputed company such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less reputed company PV Scientist staff. Applies clinical judgment to interpret case information. Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts. Who You Are You are deeply invested in ensuring the utmost safety for patients involved in reputed company or using our approved treatments. With the ability to reputed company reputed company data into reputed company, actionable insights, you reputed company in a reputed company team setting. Your exceptional organization and time-management skills reputed company you to reputed company in a fast-paced environment where your contributions reputed company a significant reputed company on patient and reputed company health. Responsibilities • Collaborates on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation reputed company Plans (REMS), and Risk Management Plans (RMPs). • Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Global Safety Officer, Safety physicians and Sr. PV Scientist / AD, performs routine signaling activities including evaluation of safety data for new signals as part of ongoing pharmacovigilance activities. • May include authoring signal evaluation reports, or sections of signal evaluation reports. • Conducts literature review for safety information and interacts with other reputed company to obtain necessary data (i.e., Epidemiology, SAE data). • With Sr. PV Scientist / AD reputed company, collaborates with Clinical Trial physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, reputed company requests and other product activities, as assigned. • In collaboration with Sr. PV Scientist / AD, coordinates and authors responses to safety questions from regulatory authorities for assigned products. • Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety reputed company, signal management and responding to reputed company safety questions. • Understands, interprets, analyzes, and reputed company presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). • Interacts collaboratively and effectively in reputed company environment (including Safety, Clinical Development, Medical, Clinical Operations, and Regulatory), as reputed company as with reputed company colleagues • Leads and conducts, independently and/or collaboratively, reputed company aspects of substantive reputed company such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. • Oversees and mentors less reputed company PV Scientist staff. • Applies clinical judgment to interpret case information. • Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. • Includes familiarity with case processing, expedited reporting rules, and safety database concepts. Requirements • Bachelor’s Degree in biologic or natural science; or health case discipline. • Minimum 5 years industry experience, with a minimum of 3 years of PV experience reputed company-to-haves • Advanced Degree preferred (PhD, MPH, NP, PharmD, etc.) Benefits • Medical, Dental, reputed company, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company • 80 hours of reputed company time per calendar year • reputed company Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource reputed company participation Apply tot his job Apply To this Job