Job Description

The Position

The aPV Unit lead is responsible for the strategic and operational leadership and oversight of all pharmacovigilance (PV) / techno vigilance (TV) activities within the Unit. The aPV Unit lead META develops and implements a comprehensive 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 aPV Unit lead META reports directly to the Associate Vice President, Head of Global QPPV Office, Global Pharmacovigilance (GPV) and coordinates a Team of PV personal. He/she works alongside the ICSR Team Lead/Leads covering the countries to share managerial tasks within the team and may undertake additional activities as requested. The aPV Unit Lead is core member of the Pharmacovigilance Global Oversight and Alignment (PV-GOAL) Steering Team.

Responsibilities

The aPV Unit Lead:

• 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 Unit aPV team to aspire to excellence and actively participate in PV improvement projects

• Ensures alignment with EU QPPV & Head Global QPPV Office on vision and strategy for the PV system within his/her Unit

• Ensures alignment with vision and strategy across aPV Units

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

The aPV Unit Lead META oversees and ensures the following activities within the countries covered by the Unit operation (exact responsibilities and accountabilities see responsibility matrix) (the Execution of certain tasks can be delegated to other team members):

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

• PV language is included in local/regional/Unit agreements, liaising with business partner as required, and ensuring maintenance of BDLM

• Review and approval of local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV/TV requirements, as applicable

• Appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures as per internal policy and in compliance with local legislations

• 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 Unit operation and actively participates in the audit and/or inspection. 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 department, to ensure quality of PV data and evaluates processes for potential improvement in efficiency and effectiveness

• Development and maintenance of local/regional/Unit PV controlled documents (i.e., SOPs, training materials, CCPD/local PSMF (where applicable)) 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 PV

• Training of Unit PV staff (including maintenance of local/regional/Unit training matrix and onboarding plans) and supports the required training of the local company staff, distributors, vendors, business partners in the countries covered by the Unit operation, including training documentation

• Provides expertise in the planning, execution, and maintenance of major projects.

• Liaises with the local/regional business units to keep them apprised of safety activities and provides input on strategic decisions (i.e., new clinical trials, product launches, etc.)

• Close collaboration and alignment with the adverse event management team including aggregate and individual case safety report (ICSR) 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.

• Assists the QPPV to fulfil her/his responsibilities to establish and maintain the Organon’s pharmacovigilance system. • Oversees and exercise authority over the functioning of the pharmacovigilance system in all relevant aspects, including its quality system.

• Assists the QPPV to ensure timely communication of emerging safety or compliance issues and in the preparation of regulatory action in response to emerging safety concerns.

• Assists the QPPV to ensure accurate, timely & complete submissions of PV documents and timely communication of safety information relevant to the benefit-risk evaluation to competent authorities. Participates on behalf of the QPPV at relevant Governance, Management and Oversight Committees and Team meetings, as described in Organon’s Procedural Documents, to ensure awareness and timely, careful consideration of pharmacovigilance issues and emerging safety concerns.

• Maintains awareness of scheduled PV audits and related corrective and preventative actions (CAPA); ensuring implementation of such CAPA plans

• Participates as necessary as well as support / advise in the context of Pharmacovigilance Inspections and audits as a delegate of the QPPV.

• Has broad oversight responsibilities for all aspects related to the global Pharmacovigilance system and as such interacts closely, when required together with the QPPV or in her/his absence, with the designated GPV staff, and other key stakeholders. • Reports safety issues and concerns to Organon Senior Management (including the QPPV) as appropriate.

• Review and approval of delegated PSUR/PBRER, DSUR, RMP and other aggregate reports, on behalf of the QPPV.

• Provides risk management guidance, as per legislation, regarding the development, implementation, and execution of risk minimization strategy.

Required Education, Experience and Skills

• In-depth knowledge of PV/TV regulations and guidelines for countries covered by the Unit operation and be an expert in PV/TV processes and activities

• He/she should have robust foundation in Pharmacovigilance with at least 8 years of industry experience in pharmacovigilance and supervisory experience managing people/teams/contractors.

• The incumbent must have a health, life science, or medical science degree (Medical Doctor or PhD/MSc/Pha) and be fluent in English (written and spoken).

• Excellent communication and time management skills

• Able to interface broadly with colleagues within related functions and cross functionally

• Work independently with no supervision except in the most complex of situations

• Dedicated, responsible and flexible

• Ethical, authentic, and transparent. Demonstrates integrity and inspires trust (internally and externally)

• Knowledge of META Market

• Result-oriented • Strong problem-solving approach

• Embrace change • Entrepreneurial

• A strong focus on the patient in all decision-making Qualifications Skills (professional and/or technical)

• In-depth knowledge of pharmacovigilance regulations and guidelines

• Strong leadership skills at all management levels - people management experience.

• Broad scientific and medical knowledge, with continuous expansion and learning ability

• Excellent organizational and project management skills

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:R536858