Zoetis is currently looking for a Global Pharmacovigilance Medical Manager to join our team. In this role you'll contribute to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including: electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE submissions to CVM, pharmacovigilance SOPs, and Signal Management responsibilities.
Responsibilities:
Good understanding of the ADE reporting regulations (US and EU) and of product trending standards.
Collaborate with signal management team regarding validation activities for assigned products (including signal detection) to comply with FDA/USDA/EU expectations and to better understand the safety and efficacy profiles of Zoetis products post-marketing.
Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders and make recommendations regarding potential safety and efficacy profile adjustments.
Provide input for negotiations with regulatory agencies regarding submission of ADE reports as well as for responses to these agencies about product safety and efficacy issues.
Assist in the design pharmacovigilance policies as needed.
Assist in the maintenance of a pharmacovigilance electronic system from a data capture, trend analysis and regulatory submission perspective as necessary.
Function as Pharmacovigilance subject matter expert for assigned product group(s).
Provide pharmacovigilance input for advertising and promotional material upon request.
Risk Mitigation in support of Global Manufacturing and Quality and Regulatory label defense activities.
Complete PV Data requests and Health Hazard Assessments for assigned products upon request.
Basic Qualifications:
DVM (Doctor of Veterinary Medicine) or equivalent veterinary degree advanced degree (e.g., MSc, PhD) in pharmacology, toxicology, or related field
3+ years of experience in the Pharmaceutical Industry
Experience with FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting
Experience in reviewing and analyzing pharmacovigilance data to develop trending reports
Preferred Qualifications:
Strong interpersonal skills, ability to work under pressure and in a highly matrix environment
Experience with database software and pharmacovigilance systems is desirable
Ability to lead/mentor others
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors.
Base Pay Range: $91,000 - $131,000
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors.
Base Pay Range: $103,000 - $148,000
[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.]
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time
Regular
Colleague
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Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [email protected] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
