HireDiversity

Horsham, PA, US

Sr. Pharmacovigilance Scientist, Exposure Estimation-7542130114

Description

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is recruiting for a Sr. Pharmacovigilance Scientist, Exposure Estimation. This position is located in Horsham, PA.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Sr. Pharmacovigilance Scientist, Exposure Estimation, is responsible for providing exposure estimation reports using established algorithms in support of ad hoc reports, aggregate reports and other documents where exposure information is needed. To accomplish this, the Sr. Pharmacovigilance Scientist will analyze internal sales data, and internal and external marketing and prescriptions data (from providers such as IMS) to provide estimates of patient exposure to Johnson & Johnson marketed products.

The Sr. Pharmacovigilance Scientist will also be responsible for the QC and review of exposure sections for Periodic Safety Update Reports (PSURs) and Ad Hoc Reports and for comparing exposure estimates from last report to current report and identifying and resolving inconsistencies. This may require obtaining corrected or additional input data, recalculating previous exposure estimates, or confirming that appropriate units were used in the calculations.

Additional responsibilities of the Sr. Pharmacovigilance Scientist, Exposure Estimation include the following: participate in cross-functional development of analytic services; determine whether internal sales information is complete, and if not, contact other internal sources obtain additional data; review previously issued safety reports to identify the appropriate exposure algorithm for each product, and apply that algorithm for future reports; document exposure algorithms used, errors encountered, and discrepancies resolved; prepare text that states the exposure estimate and how it was derived (to be included in PSUR); and maintain spreadsheet of exposure requests and reports provided, including timeliness of delivery. The Sr. Pharmacovigilance Scientist may also be involved in other projects as needed.

Qualifications


An advanced degree (e.g.: Masters, PharmD, etc) in math, statistics or a healthcare related discipline is required for this position. Candidates must possess a minimum of 3 years of pharmaceutical/biotech industry experience. At least 1 year of pharmacovigilance/drug safety experience is highly preferred.

Candidate must have working knowledge of scientific units as applied to drug doses as well as knowledge of drug delivery systems or route of administration. Working knowledge of US and Ex-US sources of market research data for large and small molecules is required. Advanced knowledge of MS Excel and solid math skills is also required. Project management skills/training/certifications are highly preferred.

The ability to effectively manage work with multiple deadlines is required and essential for success, as is attention to detail and excellent written communication skills. Candidates should be comfortable with email as the main means of communication, as recipients of the exposure estimates are located all over the world.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)