Senior Manager, Pharmacovigilance Quality and Compliance
Posted on Apr 6, 2021 by Myovant Sciences Ltd.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Pharmacovigilance Quality and Compliance. The position reports to the Director, Pharmacovigilance Quality and Compliance. The location of the position is in Brisbane, CA.
The Senior Manager, Pharmacovigilance Quality and Compliance manages, maintains, and ensures compliance with the pharmacovigilance quality management system, including but not limited to policies, procedures, manuals, training, surveillance and key performance metrics. The Senior Manager assists in overseeing the quality of work performed by contract service providers responsible for pharmacovigilance services and partner and contract service provider compliance with pharmacovigilance agreements and safety management plans, respectively. The Senior Manager supports the department and Myovant Quality in preparing for and managing audits and inspections involving the pharmacovigilance system.
Essential Duties and Responsibilities
Participation with senior management to establish strategic plans and objectives;
Monitors and trends Drug Safety and Pharmacovigilance performance indicators;
Contributes to key compliance reports for senior management;
Collaborates with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings, root cause analysis, trend analysis, implementation of process improvement measures, and effectiveness checks;
Contributes to inspection readiness activities;
Supports the conduct of audits and inspections involving the Drug Safety department, closely collaborating with Quality in the preparation, review and approval of the audit agendas and reports;
Ensures functional lines prepare and maintain processes to support a quality pharmacovigilance system;
Contributes to standard operating procedures relevant to pharmacovigilance;
Contributes to the maintenance of the pharmacovigilance system master file;
Identify gaps in the pharmacovigilance system and implement solutions;
Assist with other Safety department activities as needed.
Core Competencies, Knowledge, and Skill Requirements
Knowledge of current US and international pharmacovigilance regulations
Effective time management and organization skills
Ability to multi-task under limited direction and on own initiative
Good interpersonal, written and verbal communication skills
Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
Daily demonstrates a positive, can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
Ability to multi-task and shift priorities quickly while working under tight deadlines.
Skilled in developing collaborative internal and external relationships.
Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Minimum Bachelors degree required preferably in healthcare or life sciences.
Minimum of 7 years relevant industry experience, which includes at least 5 years of pharmacovigilance and compliance experience, global setting preferred.