Director, Pharmacovigilance and Safety Risk Management Aegerion Pharmaceuticals, Inc.
Aegerion has contracted global Pharmacovigilance and risk management activities to a Contract Safety Organization (CSO). The Director, Pharmacovigilance will have primary responsibility for management and oversight of the CSO, and managing global pharmacovigilance and risk management activities at Aegerion whilst ensuring that these activities are in full compliance with internal company policies, as well as with all applicable regulatory requirements. This role guides internal governance processes and cross functional activities related to safety and supervises external contractual relationships covering pharmacovigilance and risk management. The ability to work in a dynamic, changing marketplace to meet corporate and patient needs is essential.
Responsible for oversight of global drug safety processes and activities in the organization
Responsible for management of the CSO who is contracted to support Aegerion?s global PV and RM programs.
Takes ownership of the quality of all drug safety programs and drug safety deliverables;
Responsible for processes and operating procedures to ensure compliance with appropriate regulations and quality standards;
Responsible for drug safety surveillance and ensures safety of drug development activities in compliance with regulatory requirements and company standard operating procedures;
Oversees the evaluation, analysis and reporting of adverse events in compliance with global safety regulations, and all company standard operating procedures and policies;
Provides input to the generation of individual Safety Data Exchange Agreements (SDEA) with international distributors, and is responsible for liaising with the distributors where applicable;
Provides general training on pharmacovigilance responsibilities to company personnel;
Provides external training to distributors on the responsibilities in the safety data exchange agreements (SDEAs);
Effectively collaborates with other relevant departments;
Coordinates the quarterly safety surveillance committee;
Develops a competent staff and external contractual relationships to ensure implementation of company and quality objectives;
Communicates effectively to management across departments and staff goals, priorities and policy;
Ensures organizational financial and strategic goals are attained with respect to PV and RM activities.
Qualifications and Experience
PharmD, and/or PhD ideal. Degree in biological science (BS, or MS, or RN) at a minimum;
Health professional with 10 (+) years of pharmacovigilance experience with global product responsibility;
Demonstrated ability to utilize effective critical thinking and problem-solving skills;
Ability to manage multiple tasks with deadlines in a fast-paced working environment;
Experience in regulatory requirements and guidelines pertaining to Drug Safety;
High attention to detail and accuracy;
Demonstrated cross-functional teamwork skills;
Excellent verbal and written communication skills;
Strong commitment to business ethics.
||Cambridge, MA |