Pharmacovigilance Manager, Aggregate & Trend Reports

Nature and Scope

The Pharmacovigilance (PV) Manager, Aggregate & Trend Reports position will lead aggregate, trend, and signal detection reporting (Periodic Reporting) for human products. The position will also lead the Periodic Reporting for veterinary products and support Veterinary Medicine by providing data for trending/signaling activities and additional ad-hoc 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 American Regent, Inc.
• Lead work with cross-functional teams in improving processes, and support safety database upgrades, within 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 owner 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/ ad hoc safety meetings. agenda, ad hoc 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) interface with the Pharmacovigilance process.
• This individual will maintain current 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 current and compliant with internal procedures and regulatory requirements.
• Assist in the development and maintenance of Department SOPs and procedures.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill 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 Microsoft Word and Microsoft Excel; ability to work independently as well as in a team environment.

• Able to manage and accomplish multiple priorities simultaneously.
• Able to lead/manage projects and work efficiently 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.

American Regent 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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