Job Description

Position Overview

The Pharmacovigilance (PV) Specialist is responsible for all PV activities and 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 drug safety oversight.

The PV Specialist will be also responsible for other activities (as delegated/assigned by their Manager) which may include but are not limited to review of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues. The PV specialist may serve as Local Responsible PV person as required per local PV legislation.

The PV specialist may also participate in certain local Regulatory Affairs (RA) activities where needed.

Primary Activities:

• Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
• Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center. He/she will also perform ICSR acknowledgments and reconciliation activities.
• 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 Programs (e.g., PSP) and/or Market Research vendor(s) related activities, as applicable.
• Serves as Subject Matter Expert (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.
• Assists in developing local procedures (in compliance with regional and global standards) for the department.
• Develops and maintains local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.
• 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. Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• Supports training of the local company staff, distributors, vendors, business partners including training documentation
• Serve as the local point of contact for the local Health Authority for PV related questions from the Health Authorities.
• May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of Business Development Lifecyle Management (BDLM) tool platform with respect to local and regional contracts.
• May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and Additional Risk Minimisation Measures (ARMMs).
• 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.

QUALIFICATIONS:

Background Requirements:

The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language(s).

We expect a minimum of 2 years of industry experience in pharmacovigilance. Our new colleague must have strong communication and time management skills and can work independently with minimal supervision.

Skills:

Primary skills include but are not limited to:

1. Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals.

2. Communication Skills: Demonstrates good communications skills to convey and receive information in English and local language(s).

3. Problem Solving: Demonstrates good skills in problem solving using creative thinking.

4. Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV activities in accordance with timelines and appropriate regulations.

5. Decision Making: Demonstrates strong skills to utilize knowledge, networks and data to make rapid and appropriate decisions with some management oversight and to determine when escalation of issues is necessary.

6. Regulatory and Compliance Management: Demonstrates knowledge of PV regulations and regulatory trends.

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:

Regular

Relocation:

No 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:

1

Requisition ID:R525794