Description
SHIFT: Day Job
SCHEDULE: Full-time
Be part of an extraordinary team
We are looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. You will thrive in a complex and collaborative environment where you take action and ownership to solve problems and lead change. Do you want to be part of a larger purpose and an evolving, high-performance culture that empowers you to make an impact?
HealthCore, Inc. works with life sciences companies, payers and providers, and government and academic organizations to provide real-world evidence in support of a wide variety of healthcare decisions. HealthCore is a proud member of the Anthem, Inc family of companies and delivers unparalleled clarity and actionable information to healthcare decision makers.
Director of Pharmacovigilance Operations
*The preferred location for this position is MA but other locations will be considered. Eligible for a remote work schedule.
Build the Possibilities. Make an extraordinary impact.
The Director of Pharmacovigilance is responsible for providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight and maintenance of safety databases, and collaboration to support clinical research risk management and pharmacovigilance.
Provides direction and oversight of the Pharmacovigilance staff regarding adverse event case management, creation and maintenance of safety databases, and clinical event adjudication. Collaborates with management and project teams to support clinical research risk management and pharmacovigilance across all projects. Mentors, trains, supervises and oversees both the project staff performing these functions, as well as the deliverables we produce for our clients and sponsors.
How you will make an impact:
- Provide leadership, mentorship, and development of drug safety pharmacovigilance (PV) personnel - Assist with the ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities and summarize the results in the product safety reports in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities - Ensure that case processing activities are being completed accurately as per regulatory requirements - Ensures compliance and quality are maintained and issues are escalated appropriately and resolved - Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents - Guide the PV team with global safety regulatory requirements to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures - Lead development and updates of case processing training materials such as standard operating procedures; lead team to create efficiencies and process improvements - Serve as PV point of contact internally and externally, as needed - Interface with sponsor Safety Teams and Investigators on key deliverables - Hire, train, coach, counsel, and evaluate performances of direct reports
Qualifications
Minimum Requirements:
- Requires a BS in a life science, nursing, pharmacy or other healthcare related profession and a minimum of 5 years of direct pharmacovigilance work experience in the pharmaceutical industry and supervisory experience; or any combination of education and experience which would provide an equivalent background.
Preferred Qualifications:
- Advanced degree, preferred. - ICSR submission experience, preferred. - Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements. - Knowledge of MedDRA and WHO Drug deliverables - Experience with overseeing and managing vendors - Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting - Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data - Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills - Ability to work independently and to work interactively with multidisciplinary teams to facilitate results - Supervisory experience, preferred.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. The health of our associates and communities is a top priority for Anthem. We require all new candidates to become vaccinated against COVID-19. If you are not vaccinated, your offer will be rescinded unless you provide - and Anthem approves - a valid religious or medical explanation as to why you are not able to get vaccinated that Anthem is able to reasonably accommodate. Anthem will also follow all relevant federal, state and local laws. Anthem, Inc. has been named as a Fortune Great Place To Work in 2021, is ranked as one of the 2021 World's Most Admired Companies among health insurers by Fortune magazine, and a Top 20 Fortune 500 Companies on Diversity and Inclusion. To learn more about our company and apply, please visit us at careers.antheminc.com. Anthem is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ability@icareerhelp.com for assistance.
REQNUMBER: PS71390-Virginia
