Manager, Risk Evaluation & Reporting

At Otsuka, the Manager, Risk Evaluation and Reporting, is a scientific function responsible for supporting a global pharmacovigilance system (both development and post marketing). Scientific functions includes signal detection, risk assessment and management, Risk Management Plan (RMP) development, aggregate safety reporting, and clinical safety surveillance.

The Manager of Risk Evaluation and Reporting will participate in pharmacovigilance activities under the direction of the Director of Risk Evaluation and Reporting. The Manager of Risk Evaluation and Reporting will function in compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure benefit-risk assessment and patient safety for our products.

Manager addresses real world issues and shows expertise within their scope. You will have influence on personal productivity and will be a main contributor to the medical safety team.

Key Job Responsibilities

• Participate in ensuring that the benefit-risk assessment is current and that any changes are following governance principles.
• Participate in monitoring the patient safety for our products.
• Help maintain compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe.
• Complete PV Assessment activities through product development, product maintenance and lifecycle management.
• Participate in activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information about status and/or challenges.
• Collaborate with important Otsuka partners for content and delivery.
• Serve as a safety scientist on the medical safety team and participate in signal detection, risk management, mitigation plans, and safety analyses for aggregate reports and Health Authority responses.
• Participate in training sessions, workshops, and conferences, and share knowledge with team members, as agreed.
• Participate in process improvement activities regarding use of routine data output review, reporting and visualization tools/systems that support medical safety activities.
• Work independently as a safety scientist.
• Report to the Director of Risk Evaluation and Reporting.

Knowledge, Skills, Competencies, Education, and Experience

Required:

• Experience mentoring others.
• Demonstrated qualities of competency, accountability, initiative, and leadership.
• Experience in process improvement programs.
• Knowledge of US, ICH and EU PV and GCP regulations.
• Experience with Risk Management and Signal Detection preferred.
• Excellent strategic decision-making and analytical skills.
• Strong leadership skills with excellent track record.
• Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint.
• Strong verbal, writing and organizational skills, including a good command of English.
• Experience with Regulatory Authority Inspections (PV and GCP); experience managing vendors.
• Medical writing experience.

Education and Related Experience

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy or nursing degree) with at least 3 years of experience in clinical, pharmacological, or related fields of expertise.

OR

• Bachelor's degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field plus 4+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industry.

#MS2

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.