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Manager United States Pharmacovigilance Case Expert

The US Pharmacovigilance(PV) Organization receives adverse event (AE) reports for cases containing adverse events reported by physicians, investigators, pharmacists, nurses, consumers, patients, and CROs (Contract Research Organizations) and the FDA for all products within the Bayer Pharmaceuticals product line including devices, pharmaceuticals and Consumer Health from a variety of US sources. The immediate and accurate prioritization of all incoming U.S. serious and non-serious adverse event reports is critical for the company to maintain compliance with local and international regulations. The Mgr, US PV Case Expert is a key player in performing Case Management activities including but not limited to litigation medical record extraction activities, intake of adverse events via email, fax and letter, performing adverse event reconciliation for internal and external partners, and the procurement of vital follow up Adverse Event information. The incumbent must possess excellent communication and organization skills and the ability to work in a fastp-aced environment. The incumbent must be able to take decisive actions related to resourcing, assignments, and prioritization of work on a daily basis as well as consistently convey professionalism when interacting with colleagues, partners, or reporters.

YOUR TASKS AND RESPONSIBILITIES

This position is located in Whippany, New Jersey.

The primary responsibilities of this role, Manager United States Pharmacovigilance Case Expert, are to:

+ Monitor Safety Database worklists for follow up action item requests and conduct follow up in accordance with Standard Operating Procedures for requests from PV Case Operations Case Management and Local Safety Teams to ensure the required number of follow up attempts have been fulfilled, according to Bayer and regulatory requirements.

+ Review, triage and prepare for processing incoming legal complaints

+ Review and extraction of medical records follow up in U.S, Litigation per FDA regulatory guidelines and Bayer SOPs

+ Perform Adverse Event reconciliation for internal and external partners

+ Perform data management activities associated with incoming routine and legal cases and associated medical records.

+ Handle reports that require local action and vendor safety report clarifications across all TAs for pharmaceuticals, devices and Consumer Health products received by US PV from PV Case Operation Case Management, including documentation of communications as applicable, by applying knowledge of FDA regulations and Bayer SOPs.

+ Communicate and collaborate with Global and Local colleagues related to safety issues and encourage open communication to achieve mutual understanding of issues/seek resolution.

+ Work cooperatively toward the identification of areas needing improvements, make valuable suggestions for improvement and develop continuous improvement methods in order to increase proficiency, accuracy and improve overall compliance within the department.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

+ Registered Pharmacist (RPH) or Doctor of Pharmacy (PharmD) with Pharmacovigilance (PV) experience

+ Demonstrated problem solving skill especially with respect to enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance documents.

+ Global safety database knowledge is strongly preferred.

+ Experience with global adverse event coding, MedDRA coding experience preferred.

+ Excellent written/oral communications skills are essential including fluency in English.

+ Experience with Medical Devices preferred.

+ Experience with consumer care products preferred.

+ Proactive behavior and ability to keep timelines.

+ High degree of responsibility and accountability.

+ Ability to develop cooperative working relationships with all levels of staff is critical

+ Applies VACC leadership behaviors and approach.

+ Demonstrates high self-awareness as well as system awareness.

+ Pro-actively asks for and gives feedback.

+ Demonstrates strategic thinking as well as good business- and external trends insights.

+ Focuses on outcomes: defines and delivers highest pipeline-, team-, talent- and organizational-impact-outcomes.

+ Collaborates with accountability: collaborates and holds each other accountable in and across teams.

+ Co-creates for customers: is close to the customer and co-creates solutions for their needs.

+ Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops.

+ Creates impact by realizing authentic self and purpose, and includes others: respects differences, embraces inclusion and shows up as the best self.

+ Dynamically allocates talents with right skill set to customer-, product- and design-teams, based on business needs and defined outcomes.

Preferred Experience:

+ Registered Pharmacist (RPH) or Doctor of Pharmacy (PharmD) with 3 years of PV experience

Employees can expect to be paid a salary of between $99,000-135,000. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 5/23/2025

\#LI-US

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer is an E-Verify Employer.

**Location:** United States : New Jersey : Whippany

**Division:** Pharmaceuticals

**Reference Code:** 845896

Contact Us

**Email:** [email protected]

**Job Segment:** Compliance, Law, Pharmacovigilance, Medical Device, Database, Legal, Healthcare, Technology