Associate Director Pharmacovigilance

For our Organon office in Paris we are currently looking for an:
**Associate Director Pharmacovigilance / Local Qualified Person for Pharmacovigilance**

To lead a team of 4 Pharmacovigilance Specialist. You will act as a Local Pharmacovigilance Qualified Person/ local responsible person for pharmacovigilance (QPPV/ LRPV) as required by local legislation. You will act as the functional link between the EUQPPV, and the Responsible Pharmacist (_Pharmacien Responsable_) within the framework of the delegation of pharmacovigilance activities, the different departments, and the PV team, which includes your back-up. You will report into the Executive Director Regulatory Affairs and Pharmacovigilance. In his absence, you may act as his back-up and manage/ organise the daily activities of the Pharmacovigilance/Regulatory Affairs department.

**Welcome to our team**

The Regulatory Affairs and Pharmacovigilance department in France consists of two distinct teams managing RA and PV activities respectively. The PV Team consists of 4 PV Specialists and Senior Specialists covering responsibilities across safety surveillance, PV compliance and case management.

**Role Responsibilities**
- Develop and maintain all PV processes in accordance with regulations, particularly European and French regulations, and internal procedures;
- Ensure the establishment of a quality system applied to PV by participating in the processes to continuously improve the quality of the system and methods relating to PV activities, including the management of PV cases, submission of periodic and individual PV reports to health authorities, management and negotiation of local pharmacovigilance agreements, local prequalification activities, stablish and manage the pharmacovigilance system on a national level;
- Oversee all daily pharmacovigilance processes and activities, such as, but not limited to, case management and monitoring activities, local literature reviews and submissions to health authorities;
- Prepare for and actively participate in audits/ inspections. Provide corrective and preventive actions (CAPAs) and follow up on CAPA commitments to respond to findings/observations and monitor them until the closure;
- Develop and update local controlled pharmacovigilance documents (i.e., SOPs, training materials, local PSMF [if applicable]) ensuring they are kept up to date and proactively identify procedural gaps to implement solutions in collaboration with all relevant stakeholders;
- Review and approve local initiatives (e.g., digital interfaces, marketing initiatives/patient programs, organized data collection systems, etc.) and other programs to ensure compliance pharmacovigilance requirements, where applicable;
- Ensure that the implementation and monitoring of risk minimization measures and additional risk minimization measures at the local level are appropriate, in accordance with department policy, and ensure compliance with local legislation;
- Act as a local expert on relevant pharmacovigilance regulations, processes and procedures.

**Qualifications, Skills and Experience**
- Pharmacist Degree or MD diploma which can be registered with the local Pharmacist Guild (section B);
- At least 7 years of experience in a pharmacovigilance role with prior experience as local RPV preferred. Prior experience in materiovigilance would be a plus;
- 3 years or more of people management experience would be preferred;
- Excellent communication and time management skills, ability to collaborate well with colleagues within related and cross-functional functions and be able to work independently without supervision in except the most complex situations;
- Advanced skills to drive change that improves processes within the company or across departments that improve quality and/or add value to the company;
- Excellent oral and written communication skills in both French and English.

**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.

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**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

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

10%

**Flexible Work Arrangements**:
Not Specified

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings