Senior Director, Global Safety Lead

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About Servier

With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs.  At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.

Role Summary

The Sr Director, Pharmacovigilance for Global Safety will work in collaboration with the Global Safety managers based in Saclay (France). The individual will manage the US Global Safety team and ensure the central coordination and up-to-date oversight of all drug safety and pharmacovigilance activities required to ensure the patients’ and clinical trial participants’ safety for the assigned oncology portfolio.  The department manager also participates in continuous development of the SOPs and improvement of the PV system. This role can also be assigned additional duties and responsibilities.

Primary Responsibilities

• Manage the assigned pharmacovigilance team, including the recruitment, training (mentoring, coaching), objective setting, professional development, annual performances reviews and direct interactions with HRs
• Maintain a program plan of all activities and deliverables related to the assigned compound’s safety
• Provide oversight and guidance for the day-to day pharmacovigilance and drug safety activities
• Participate in impact analysis of regulatory intelligence regarding her/his scope of activities
• Oversee signal detection and risk management activities for assigned development and marketed compounds
• Oversee the validation and timely completion of the aggregate safety reports for assigned development (DSUR, INDAR, etc.)  and marketed compounds (PBRER, PSUR, PADER, etc.)
• Oversee addressing and replying to Health Authorities’ safety queries
• Oversee a process for the contribution on the drafting and reviewing of all Reference Safety Information (Core Company Data Sheets, SmPC, RSI, Investigator Brochures)
• Ensure the coordination of referral procedures addressed for safety reasons
• Ensure the contribution and review of the safety part of the NDA/MAA dossier
• Implement safety communication process
• Provide the oversight and input, as needed, for all drug safety/PV issues in the clinical development plan for assigned development compounds, by overseeing the review of clinical study-related documents (concept sheets, protocols, ICF, CSR, etc.)
• Represent Benefit/Risk Evaluation unit, when needed, at Benefit/Risk and Labelling Committee or other ad hoc meetings
• Ensure any PV obligation /action mentioned in the Safety Data Exchange Agreements with business partners are implemented and followed for the assigned portfolio
• Support, when needed, due diligence activities
• Support internal PV audits and regulatory inspections

Education and Required Skills

• Credentialed as a Physician
• 10+ years of experience within the pharmaceutical industry in the PV field both in clinical and post-marketing settings and in analysis of PV data, especially for products covered by a risk management plan.
• Expert knowledge of PV processes and international regulatory requirements
• Experience as representative of PV with regulatory bodies
• Experience with Microsoft office; specifically, proficiency with Excel & Power Point and ability to learn and adapt internal tools
• Proven conceptual thinking and strategic problem-solving ability
• Ability to prioritize and lead various team members at various levels to achieve goals
• Serve as a role model, demonstrating respect and inclusion
• Proven ability to adapt to change and manage cultural change in an evolving environment
• Ability to speak forthrightly and encourage others to do the same
• Ability to propose and make decisions that benefit the Global Safety in collaboration with the line management
• Ability to foresee and identify issues and then propose and develop solutions in compliance with the legal requirements

Travel Requirements:

• This position can be remote in US with travel to Boston US HQ for team and business meetings
• International travel to Global HQ located in France a few times a year

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $300,000 - $350,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.