Pharmacovigilance Senior Specialist (Hybrid)

Job Description

The Position

The Pharmacovigilance Senior Specialist (PV Senior Specialist) will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization and reporting into the head of Japan Pharmacovigilance.

The PV Senior Specialist is responsible for all PV activities and may serve as the PV contact with local stakeholders, headquarters (HQ) and the local health authority. The PV Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight.

The Sr. Specialist is also responsible for PV activities (as delegated/assigned by their Manager) which may include but are not limited to: management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, local initiatives, SOP management, local training, communication of safety issues, people development, and/or special projects and can work on these delegated activities with minimal supervision.

The Sr. Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. In the absence of their Manager, he/she is responsible for managing all day-to-day activities of the PV and RA department and serves as their back-up.

Responsibilities:

• Serves as the back-up PV Responsible person/ Safety Management Supervisor as required per local PV legislation.
• Oversees all daily PV processes and activities within the countries covered by the country operation as required.
• Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
• Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations.
• Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
• Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
• Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
• Participates in and supports audits of contractual partners/vendors as necessary.
• May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
• Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
• Develops and maintains local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• Leads the training of PV staff and supports the required training of the local company staff, distributors, vendors, business partners including training documentation.
• May be assigned responsible for ensuring PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of the database related business partner with respect to local and regional contracts.
• May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally.
• Serve as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
• Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight Participate on local company committees and councils (as appropriate) for matters impacting PV

Required Education, Experience and Skills:

• Over 15 years of experience in pharmacovigilance work
• Undergraduate degree or above (life science department)
• Japanese : Native level, English: Business Level
• Management experience of group leader level
• Willingness, positivity, and flexibility to take on new things and new tasks.
• Attitude that emphasizes compliance, responsibility, courage, and integrity
• Negotiation skills
• Leadership

Preferred Experience and Skills:

• Knowledge of medical Device
• Knowledge of handling safety information of investigational drugs

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R525722