Drug Safety Consultant II

Job Description

Job Summary:

• PV Scientist serves as a product lead for Pharmacovigilance activities within Safety.
• The PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities.
• The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

Duties and Responsibilities:

• Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
• Includes synthesis of data from multiple sources and authoring signal evaluation reports.
• Support and/or leads signaling review process and product Safety Signaling Team meetings.
• Manages literature review for safety information.
• Support and/or leads process for responding to safety questions from regulatory authorities while collaborating with cross-functional team as necessary.
• Support and/or leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
• Responsible for day-to-day safety operations and safety management plans for assigned clinical trials.

Qualifications Required Skills:

• Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
• Bachelor’s Degree in biologic or natural science; or health case discipline required.
• Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
• Knowledge of MedDRA terminology and its application.
• Must have excellent analytical and problem-solving ability.
• Strong computer skills and advanced application MS capability desirable, particularly Excel.
• Ability to work in fast-paced environment with multiple competing priorities.