Senior Specialist Drug Safety

Job Description

The position

The Senior Specialist P harmacovigilance (PV) Unit is responsible for PV activities of countries covered by the PV Unit and

• Serves as the PV contact with local/regional stakeholders, headquarters (HQ) and local health authorities

• 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.

• Responsible as Subject Matter Expert (SME) for certain PV activities (as delegated/assigned by the Unit Lead) which may include but are not limited to: case management and literature processes, compliance activities, training and maintenance of procedural documents, audits and inspections including related readiness activities, Aggregate Reports and Risk Management activities, Safety Data Source topics, PSMF activities, BP and vendor management including reconciliation activities, Business Continuity in Pharmacovigilance, Safety Signal management, medical devices and/or special projects and can work on these delegated activities with minimal supervision.

• Serves as the Local Responsible PV person as required per local PV legislation.

Countries of responsibility (MAH): Belgium, Luxembourg and The Netherlands

Responsibilities

The Senior Specialist PV:

• Serves as the PV Responsible person/LQPPV as required per local PV legislation.

• Oversees and supports all daily PV processes and activities within the countries covered by the Unit as required.

• Responsible as SME for execution of certain PV processes and activities within the Unit in alignment with PV systems and their associated Quality Management System, following company and Unit SOPs, company Policies and Procedures and country/regional legislation

• May serve as SME Lead of an a PV SME Group, coordinating SME group activities, ensures cross functional stakeholder collaboration and harmonization of processes between Units, drives improvement and simplification initiatives in this area and represents this a PV SME group in company committees or councils if necessary.

The Senior Specialist PV:

• 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 with Unit 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/regional 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/regional 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/regional country licensing agreements.

• Develops/Assists in developing company procedures (in compliance with regional and global standards) to ensure current quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.

• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.

• Leads the training of PV staff (including maintenance of the local training matrix and onboarding plans) and supports the required training of the local company staff, distributors, vendors, business partners including training documentation.

• Ensures that PV language is included in local/regional agreements, liaising with business partner as required, and ensuring maintenance of BDLM with respect to local and regional contracts.

• 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/cluster 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

List not exhaustive

Required Education, Experience, and Skills

• Excellent knowledge of the Unit and European pharmacovigilance regulations and expertise in the main processes and activities of a pharmacovigilance system.

• Good problem-solving and decision-making skills using creative thinking, knowledge, networks and data from relevant stakeholders to make timely and appropriate decisions with some oversight from management and to determine when escalation is necessary

• Good change management skills to respond to new and complex situations, assess the impact of changes and propose appropriate responses or solutions.

• Ability to work in a team and communicate, work in partnership with others in the company, generate and enable constructive exchanges to ensure a common understanding of objectives and achieve common goals and work within the team and across the company, and with external partners, with the aim of obtaining the collaboration of interested parties.

• Pronounced ability in project management and strong skills in the ability to organize work efforts, prioritize tasks and use appropriate means to support pharmacovigilance activities in accordance with appropriate timelines and regulations

• Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals.

• Demonstrates strong communications skills to convey and receive information in English and local language.  Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills.

• Demonstrates skills in problem solving using creative thinking, gathers data from appropriate stakeholders and ability to respond to new complex situations and influence organization direction.

• Demonstrates strong skills to drive change that enhances processes within the company or cross-functionally within MRL/MMD/GHH that improve quality and /or add value to the business.

• Demonstrates strong 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.

• 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.

• Demonstrates knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improve the quality of business and functional area outputs.

• Demonstrates knowledge of PV regulations and regulatory trends.

• He/she should have a minimum of 4 years of industry experience in pharmacovigilance.

• 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 French and Dutch.

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:

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: R533617