PV Risk Minimization Physician & Deputy EU QPPV

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title : PV Risk Minimization Physician & Deputy EU QPPV

Location : Paris La Défense

Job description :

The core mission of the Global R&D Pharmacovigilance department is as follows:

• Protect Galderma customers from safety issues;
  
• Promote safe and effective use of Galderma products.
  
• Lead the scientific and operational activities - across Galderma's portfolio - relating to the detection, assessment, and understanding of adverse effects and lead efforts to optimize the risk benefit of the portfolio through the continuous monitoring of safety data and implementation of risk minimization strategies.
  
• Ensure regulatory compliance in all markets.
  

The PV Risk Minimization Physician's specific mission is to:

• Ensure that the benefit risk assessment is current for a specific set or category of Galderma products and that any change is handled as per Galderma's decision-making principles.
  
• Be accountable, in a matrix organization, for the benefit risk activities including signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, and medical review of ICSRs as needed.
  
• Be responsible for the medical/scientific review of safety related information in CCDS, CSI, product labelling, investigator brochures, DSUR/PSUR/PBRER as well as in responses to specific questions from Health Authorities.
  
• The PV Risk Minimization Physician also acts as deputy European QPPV and as such, manages the responsibilities of the EU QPPV when required.
  
• He/She reports directly to the Head of PV Risk Management.
  

Key responsibilities:

• Propose measures aimed at minimizing risks for In-line/Commercial medicinal products.
  
• Review/provide input to Aggregate Reports (PSUR, PBRER), Signal Evaluation Reports and Development Safety Update Reports (DSURs).
  
• Lead the drafting and review of EU and regional Risk Management Plans (RMP).
  
• Provide medical input to safety topics reviewed during meetings of various governance meetings (Labeling Review Committee, PQS Committee, etc.)
  
• Perform signal detection and lead the validation of signals for In-line/Commercial medicinal products, based on the review of single cases and aggregate data, and escalate such signals as appropriate during ad-hoc or regular governance meetings.
  
• Review/provide input to Common Technical Document (CTD) (or equivalent) for Dossier Registration and product label.
  
• Prepare answers to safety-related questions from Regulatory agencies during review or ad-hoc procedures.
  
• Organize regular (i.e., at predefined milestones) Product Safety Team (PST) and Portfolio Safety Committee (PSC) meetings for products under his/her scope of responsibilities
  
• Contribute to Due Diligences, as needed.
  
• Medical review of ICSRs as needed.
  
• Participate as Subject Matter Expert during audits and inspections
  
• Contribute to the creation and maintenance of the Global R&D Pharmacovigilance department's controlled quality documents (SOPs, Work Instructions etc)
  
• Ensure effective and close collaboration with various functions at Global and Regional levels, including Regulatory Affairs, Medical Affairs, Clinical Development, Global Commercial groups, Local Safety Officers and other stakeholders.
  

Skills & Qualifications

• Medical degree (MD or equivalent)
  
• At least 15 years of experience at a global level in pharmaceutical companies, with significant experience and knowledge of international post marketing regulations applicable to medicinal products.
  
• Expert knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, the product registration process (e.g. BLA, MAA, etc) and post-marketing activities.
  
• Interactions with Health Authorities in the US, EU and other geographies to address safety medical questions.
  
• Experience with QPPV function would be a significant relevant advantage.
  
• Knowledge of dermatology prescription products (including biologics) is highly desirable.
  
• A self-starter with a proactive dynamic/agile mindset who can take the initiative without being asked and who can act independently with minimum oversight.
  
• Fluency in English. Fluency in French would be an advantage.
  

What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. In addition, we want to ensure our commitment towards equity and inclusion by offering a competitive and fair compensation with a bonus structure and benefit package. You become part of a hybrid culture to ensure innovation and collaboration together with the right work-life balance. You will have a development plan, during which a personalized career path will be established, and you join a growing organization that believes in ownership from day one where everyone is empowered to grow and to take on accountability.

Next Steps

• Please send your CV in English and after positive review, a first virtual conversation with Talent Acquisition will take place (FYI: just need to upload CV, can ignore the manual fields requested after uploading CV)
  
• The next step is a virtual conversation with the hiring manager
  
• The final step is a panel conversation with the extended team
  

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.