VP Head of Pharmacovigilance
2 weeks ago
Position Summary
The Vice President, Head of Pharmacovigilance oversees all adverse event management, safety surveillance and signal detection practices for Calliditas' portfolio of development and marketed products, and leads the management of all collaborative, partner and contract research organisation relationships (with respect to pharmacovigilance).
The Vice President, Head of Pharmacovigilance must have executive presence, excellent people management skills, advanced safety data review/analysis experience, superb written and verbal communication skills, as well as hands-on pharmacovigilance experience with a proven track record of significant accomplishment.
The Vice President, Head of Pharmacovigilance will report to the Chief Medical Officer (CMO) and be a part of the Clinical Team. The position will be placed at Calliditas headquarter in central Stockholm.
Tasks and responsibilities/accountabilities:
- Lead the Clinical Safety/ Pharmacovigilance function and continue to build the group in line with the company's growth to ensure adequate staffing with an appropriate mix of skills;
- Manage all pre- and post-marketing safety reporting and safety surveillance activities for Calliditas' products (both investigational and marketed) throughout their lifecycle in compliance with all relevant internal and external legal requirements, guidelines, policies and procedures;
- Develop, implement and maintain safety surveillance processes and practices that are compliant, robust, and appropriate to support Calliditas' business model;
- Execute all safety surveillance activities ensuring quality, compliance and key performance metrics met for ICSR management, signal and risk management activities, aggregate safety reporting, core safety labelling, responses to regulatory requests for safety information and others;
- Lead and/or provide input to global safety strategy for all programs ensuring proactive and continuous review and assessment of pre- clinical, clinical, and post-marketing safety data to ensure clearly defined benefit-risk profile for all Calliditas programs in collaboration with key stakeholders;
- Establish effective collaboration with Clinical Operations, Regulatory Affairs, Medical Affairs and other functional areas to align on harmonized approach in identifying, evaluating, validating, and communicating safety issues;
- Coordinate safety data review activities to support program milestones, Data Monitoring Committees, in collaboration with the Clinical Department and other key stakeholders.
Competence requirements for the position (education and experience)
- Healthcare professional degree (MD, MPH, PharmD, PhD, RPH);
- A minimum of 12 years in a senior/advanced international Clinical Safety/ Pharmacovigilance role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity; other relevant experience may be considered;
- Desire to manage and develop people and team, with strong people management skills and willingness to help others succeed;
- Outstanding leadership qualities with technical and emotional intelligence;
- Excellent communication and influencing skills within the function (up and down) as well as cross-functional; success influencing executives and senior level scientific management as well as external representation of company;
- High level of initiative and independence;
- Ability to navigate fast-paced and dynamic work environment in a small company, biotech setting; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must.
- Demonstrated knowledge of pharmaceutical research and development, global safety and PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post-marketing safety and their interpretation;
- Experience working in innovative and ground-breaking therapies with demonstrated track record of accomplishments with high visibility programs;
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance with respect to Clinical Safety/ Pharmacovigilance;
- Experience in developing and implementing risk management strategies and plans;
- Working knowledge of industry standard safety databases (ARGUS and ARISg), Regulatory databases, and other electronic data capture systems;
- MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries;
- Real world experience supporting PV audits and/or health authority inspections
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA-Nephropathy and a rapidly growing commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
- Fast paced small company environment
- A unique corporate culture
- Dedicated, experienced and highly skilled colleagues
- Participate on bonus and benefit programs
All applications are handled by Life Science Medics
Life Science Medics have been retained on this project and working exclusively with Calliditas to lead the recruitment process for this role. We kindly request that other external recruitment companies refrain from contacting Life Science Medics and Calliditas about this job posting.
Please note as part of our recruitment process, you will be expected to complete a written questionnaire exploring aspects of your background and to have an in-depth interview with a representative of Life Science Medics prior to the confirmation of your candidacy. To apply for this position or have an initial confidential discussion please reach out to Rebecca Bray, Director at Life Science Medics.
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Life Science Medics Ltd, Global Executive Search Leaders for MDs in the Life Science Industry
About Us
Calliditas is a commercial stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Calliditas' lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO, conditional marketing authorization by the European Commission under the trade name KINPEYGO and by China's National Medical Products Administration (NMPA) Nefecon. TARPEYO, KINPEYGO and Nefecon are the first and only treatments approved for IgA nephropathy.
Calliditas also has a pipeline in orphan-focused indications. Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.
Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
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Stockholm, Stockholm, Sweden Pharmalink Full timePosition SummaryThe Vice President, Head of Pharmacovigilance oversees all adverse event management, safety surveillance and signal detection practices for Calliditas' portfolio of development and marketed products, and leads the management of all collaborative, partner and contract research organisation relationships (with respect to pharmacovigilance). The...
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