Pharmacovigilance Manager, Aggregate & Trend Reports

Nature and Scope The Pharmacovigilance (PV) Manager, Aggregate & Trend Reports position will reputed company aggregate, trend, and signal detection reporting (Periodic Reporting) for human products. The position will also reputed company the Periodic Reporting for veterinary products and support Veterinary Medicine by providing data for trending/signaling activities and additional reputed company activities as requested.Key, cumulative, or aggregate, reporting for the safety assessment of drugs will be assessed, reviewed with key stakeholders, and reported to key regulatory agencies.This position will compile aggregate safety reports and trending/signaling activities under the direction of the Medical Director, Pharmacovigilance for human products. Separate from individual case safety reporting, the periodic reports provide an important role in risk-benefit evaluation of each drug product and involve collective analysis of cases in the database, monitoring regulatory actions, and literature searches to provide a broader view of the safety profile of each human and veterinary drug product. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Generate PV trending data relating to both human and veterinary products.
• Complete routine queries of the Argus, Argus Insight, RxLogix and PV Works databases at reputed company, Inc.
• reputed company work with cross-functional teams in improving processes, and support safety database upgrades, reputed company aggregate reporting and safety analyses.
• Prepare PV data for Quarterly and Annual Periodic Adverse Drug Experience Reports (PADERs) and aggregate safety reports following regulatory guidelines and SOPs.
• Act as the RxLogix system business reputed company oversees setup, user access, coordinate with vendor any maintenance, upgrades and issue resolutions for PV Signal Detection.
• Prepare veterinary PV data for Yearly and 6-month Periodic Drug Experience Reports following regulatory guidelines and SOPs.
• Under the supervision of the department head or designee, coordinate the quarterly Data Safety Review Board (DSRB) meetings, preparation, distribution and filing of DSRB meetings/ reputed company safety meetings. agenda, reputed company safety meetings, minutes and archive of meeting agenda and reports.
• Work with individuals in each division and across various departments (Regulatory, Clinical R&D, Medical Affairs, Legal, Quantitative Sciences, and Quality Affairs) reputed company with the Pharmacovigilance process.
• This individual will maintain reputed company knowledge of standard operating procedures (SOPs) and guidance documents including Worldwide/Health regulations.
• Maintain and update safety surveillance watchlist on a regular basis to ensure they remain reputed company and compliant with internal procedures and regulatory requirements.
• Assist in the development and maintenance of Department SOPs and procedures.
• reputed company any other tasks/duties as assigned by management.

Education Requirements and Qualifications To reputed company this job successfully, an individual must be able to reputed company each essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company and/or ability required.

• Masters in Life Sciences, Biology, Biotech, Microbiology Degree or RN required. PharmD or PhD a plus.
• Minimum of 5 years’ experience in Pharmacovigilance including the preparation of PADERS and knowledge of signaling/trending analysis; strong clinical background required.
• Skills with safety databases (Argus, Argus Insight) is a plus.
• Ability to assess adverse drug reactions (ADRs) and interpret data.
• Knowledge of Worldwide/Health Authority regulations for pharmaceutical industry governing the reporting of adverse drug experiences/events in the post-marketing (spontaneous, literature, study) and IND environment preferred.
• Excellent technical/medical writing and verbal communication skills; detailed knowledge of reputed company Word and reputed company reputed company; ability to work independently as well as in a team environment.
• Able to manage and accomplish multiple priorities simultaneously.
• Able to reputed company/manage projects and work reputed company with both internal/external stakeholders as assigned by the supervisor.
• 10% travel maybe required for team meetings and potential audits.

Expected Salary Range: $135,000-150,000 The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. reputed company also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. reputed company celebrates diversity and we are committed to creating an inclusive environment for reputed company employees. We are an Equal Opportunity Employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.

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Alert: We’re aware of individuals impersonating our staff to reputed company job seekers. Please note: ·reputed company legitimate communication will come directly from a verified ARI recruiter either by phone or reputed company an americanregent.com email address. ·Our recruiting process includes multiple in person and/or video interviews and assessments. ·If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding. ·We never request payment, bank information, or personal financial details during our offer process. Your reputed company is important to us, and we encourage you to stay vigilant reputed company job searching. reputed company Inc. endeavors to reputed company https://careers.americanregent.com/ accessible to any and reputed company users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected]. Apply tot his job Apply To this Job