Manager, Pharmacovigilance Operations

The Manager, PV Operations - GPIO, is a key member of the Global Pharmacovigilance Intelligence Office (GPIO) who is contributing to the success of Parexel Global Safety Reporting Group (GPRG) and other departments by providing safety reporting related regulatory intelligence for the business. The Manager, PV operations, GPIO, works closely with the GPIO team, its associates and management to deliver quality output for our internal and external clients, improve processes and enhance GPIO services offered.

Key Duties Include:

•Collaborating with and assisting the Global Pharmacovigilance Intelligence Office (GPIO) team in operational day-to-day activities

•Leading and participating in functional internal and external team meetings, act as a point of contact with selected clients, as needed.

•Collaborating with senior management in assignment of workload, evaluating team performance and identify areas of improvement

• Ensuring communication of important decisions/policies discussed with senior management or the client to the team

• Ensuring to meet the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings for regulatory intelligence for both internal and external clients

• Providing functional expertise/oversight of regulatory requirements and for PV Operations staff (both pre- and post-marketing setting)

• Responsible for contract GPIO related management

• Prepare for, participate and respond to internal/external audits/inspections, as needed

• Taking suitable action as per client feedback for any performance or process related concerns • Providing project updates to the Senior Management on periodic basis

• Contribute to and/or participate in new business development tasks: i.e.: providing input and attend proposal development/ bid defense meetings •Maintaining up-to-date knowledge of relevant regulations and client’s and Parexel’s Standard Operating Procedures

Requirements:

· Degree in a Science related field is preferred (Health Science, Pharmacy, General Science, Medicine, etc)

· Proficiency in English is a must, proficiency in other languages is a strong advantage.

· 5+ years in pharmacovigilance experience, including case processing, regulatory reporting in clinical trial and/or post marketing setting. Having experience with both is an asset.

· Demonstrated understanding of PV concepts, processes and requirements.

· Demonstrated knowledge of major global regulations (EMA, FDA, HRA, PDMA, HC, TGMA) related to safety reporting for the full life cycle of a medicinal product, familiarity with country level safety reporting and pharmacovigilance reporting guidelines and regulations.

· Experience with medical device and vaccine safety reporting, knowledge of related regulatory requirements is a very strong asset.

Skills:

· Strong collaboration, communication

· Analytical thinking, ability to interpret and evaluate complex regulatory ideas and changes, and their impact on PV process and safety reporting.

· Ability to work as an individual and as part of a team, self-starter and problem solver.

· Fast learner: ability to read, review, comprehend and interpret large volumes of information on a regular basis.

· Motivated, open-minded personality ready to share ideas and knowledge to contribute to the growth of GPIO.

· Safety System Admin experience (Preferably Argus), ideally, with some ability to read/write/comprehend SQL, PL/SQL.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.