Job Description

The Position

The ICSR Unit lead is responsible for the strategic and operational leadership and oversight of all ICSR related pharmacovigilance (PV)/techno vigilance (TV) activities within the Unit.

The ICSR Unit lead >Name of Unit< develops and implements a comprehensive ICSR Unit PV strategy aligned with the company´s vision. He/She partners with local/country/regional and global stakeholders (Global Pharmacovigilance, Medical Affairs, Regulatory Affairs, Commercial, …) to ensure effective communication and alignment on PV/TV matters.

The ICSR Unit lead >Name of Unit< reports directly to the PV Operations case Processing Team Lead and coordinates a Team of PV personal. He/she works alongside the aPV Unit Lead/Leads covering the countries to share managerial tasks within the team and may undertake additional activities as requested.

Responsibilities

Additionally, the ICSR Unit lead serves as PVR/LQPPV/deputy QPPV for >countries<

The ICSR Unit Lead >name of Unit< oversees and ensures the following activities within the countries covered by the Unit operation (exact responsibilities and accountabilities see responsibility matrix):

• Ensures that the responsibility matrix for all countries within his/her Unit is always up-to-date and gives a clear overview of responsibilities and accountabilities for each task in each country.

• Develops and implements PV quality management systems on a Unit level

• Establishes and manages aPV Unit PV budgets where applicable

• Energizes, motivates and establishes a high performing ICSR Unit team to aspire to excellence and actively participate in PV improvement projects

• Ensures alignment with vision and strategy across all PV Units

• Facilitates, develop and implement plans for measuring and improving employee engagement

• Coordination of adverse event management including aggregate and individual case safety report (ICSR)/Techno vigilance health authority submissions

• Reconciliation processes of AE reports received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.

• Coordination of filing, storage and archiving safety-related documentation in accordance with company’s policies and local requirements.

• Representation of PV in cross-functional organizational and alliance partner forums as needed.

• Unit and local Subject Matter Expert on relevant PV regulations, processes and procedures.

• Reporting rules (for both drugs and devices) are set up in a timely manner and maintained during its lifecycle

• Compliance activities and preparation of necessary corrective actions locally for late reporting countries covered by the Unit operation

• Prepares for audits/inspections for countries covered by the ICSR Unit operation and actively participates in the audit and/or inspection. For topics under her/his responsibility provides recommendations of corrective and preventive actions (CAPA) and track CAPA commitments to address findings/observations and monitors until closure.

• Participation in and support in audits of contractual partners/vendors as necessary.

• Definition and development of local standards and procedures (in compliance with local, regional and global standards) for the ICSR department, to ensure quality of PV data and evaluate processes for potential improvement in efficiency and effectiveness.

• Development and maintenance of local/regional/Unit PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.

• Proactive identification of procedural gaps and challenges and implementation of solutions in collaboration with all affected stakeholders.

• Participation on local/regional company committees and councils (as appropriate) for matters impacting ICSR Unit

• Training of ICSR Unit PV staff (including maintenance of local/regional/Unit training matrix and onboarding plans)

• Provides expertise in the planning, execution, and maintenance of major projects (as applicable).

• Close collaboration and alignment with the aPV Unit/Units

The Execution of certain tasks can be delegated to other team members.

Required Skills

The ICSR Unit Lead >name of Unit< must have in-depth knowledge of PV/TV regulations for countries covered by the Unit operation and be an expert in PV/TV processes and activities under his/her responsibility.

He/she is expected to have excellent communication and time management skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.

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

2. Communication Skills: Demonstrates advanced communications skills to convey and receive information in English. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills and ability to adapt presentations to various audiences.

3. Problem Solving: Demonstrates advanced skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.

4. Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.

5. Project Management: Demonstrates advanced skills in the ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.

6. Decision Making: Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

7. Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.

8. Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure the functional areas within the company are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

Required Experience

He/she should have at least 6 years of industry experience in Pharmacovigilance/Regulatory Affairs and supervisory experience managing people/teams/contractors.

Required Education

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).

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.

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:R533777