Global Pharmacovigilance Medical Manager

reputed company is currently looking for a Global Pharmacovigilance Medical Manager to join reputed company. 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 reputed company with FDA/USDA/EU expectations and to reputed company understand the safety and efficacy profiles of reputed company products post-marketing.
• Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders and reputed company 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 reputed company 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 reputed company 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 reputed company/mentor others

The following reputed company pay range reflects the anticipated reputed company pay for this position if a selected candidate were to be located in (Colorado). reputed company pay may vary based reputed company and other factors. reputed company Pay Range: $91,000 - $131,000 The following reputed company pay range reflects the anticipated reputed company pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). reputed company pay may vary based reputed company and other factors. reputed company 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 Any unsolicited resumes sent to reputed company from a third party, such as an Agency recruiter, including unsolicited resumes sent to a reputed company mailing address, fax machine or email address, directly to reputed company employees, or to reputed company resume database will be considered reputed company property. reputed company will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. reputed company will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. reputed company is committed to equal opportunity in the terms and conditions of employment for reputed company employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national reputed company, 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 reputed company Colleague Services at zoetiscolleagueservices@reputed company.com to request an accommodation. reputed company also complies with reputed company applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. reputed company applicants must possess or obtain authorization to work in the US for reputed company. reputed company 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 reputed company seeks information reputed company to job applications from candidates for jobs in the U.S. solely reputed company the following: (1) our company website at www.reputed company.com/careers site, or (2) reputed company email to/from addresses using only the reputed company domain of "@reputed company.reputed company addition, reputed company does not use reputed company Hangout for any recruitment reputed company activities. Any solicitation or request for information reputed company to job applications with reputed company reputed company any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, reputed company will never ask candidates to reputed company any type of personal financial investment reputed company to gaining employment with reputed company. Apply tot his job Apply To this Job