- The SABR Safety Physician EU+ is a Safety MD with expert medical/scientific knowledge on the benefit-risk profile of one or more company products that can be investigational or marketed. This role is highly visible with the global SABR function.
- The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of company therapies.
- This position is the SABR point responsible for EU and Global Emerging Markets (Asia PAC, Middle East, Africa and South-America).
- The SABR MD EU+ works in close collaboration with product Global Safety Officers and EU+ Regulatory Affairs to seamlessly and proactively devise and implement strategic programs; execute the product specific benefit/risk plan and support or directly interface with Health Authorities in EU+ geographies as appropriate on product safety issues and product filings.
- The individual who assumes this position will interact with multiple levels of management within the company , as well as global regulatory authorities.
- Accountable for proactively drafting and implementing an EU+ strategic plan in collaboration with EU Medical and Regulatory Affairs for EU+ geographies.
- Safety content of local labels: Responsible for labelling activities in EU+ geographies; Signatory of safety content of local labels in EU+ geographies.
- Point responsible for SABR content of responses to product regulatory queries originating from EU+ geographies. Will work in coordination with GSO and PV Scientist to align on response strategy and authorship responsibilities.
- Core Risk Management Plan (RMP)and EU-RMP: Responsible for the generation of the core and EU RMP for new product/indication filings with support of Epidemiology and Medical Writing. Responsible for post-approval maintenance of core RMP and EU RMP for assigned product.
- Post-authorization safety studies and other assigned studies in EU+ geographies: Responsible for overseeing and a signatory for PASS in EU+ geographies. Accountable for input on protocol design, ICF Safety content, study life-cycle activities including participation in interim and end-of-study CSR activities; Attends assigned study management team meetings as appropriate.
- Active member/strategic contributor to the SABR medical team - this includes, but is not limited to, leading/ participating in product related SABR periodic review meetings, PSUR kick off and preparatory meetings, regular 1:1 meetings with the GSO and SABR product medical working team meetings , Monthly product Safety Surveillance Team meetings and (ad hoc) product Safety Monitoring Committee meetings;
- Serves as a primary SABR contact for other functions with focus on regulatory and medical affairs in EU+ geographies; support of or directly interface with Health Authorities as appropriate on product safety issues and product filings;
- Responsible for input to safety and benefit-risk related topics for regulatory responses to Health Authorities in EU+ geographies;
- May represent SABR at Program Executive Team on EU+ related issues;
- Provides support to the Office of QPPV as appropriate.
- Minimum 5 year experience in the pharmaceutical industry preferably within , progressive, fast-paced, sophisticated biotech and/or pharmaceutical companies.
- Previous experience in drug safety) which includes prior direct interactions with EU and ROW regulatory authorities is beneficial but not a pre-requisite
- Demonstrated ability to lead and collaborate within highly complex organizations, across functions and geographies;
- Preferably has prior experience in clinical development;
- Strong verbal and written communication skills;
- Demonstrated sense of urgency and accountability for both individual and team-owned work products.
- Dynamic, innovative, nimble, proactive, results-driven, with an entrepreneurial “can do” attitude
- Well-rounded combination of strategic perspective, tactical operational expertise, strong analytical skills, and sound judgment who can think broadly, coupled with an aptitude to challenge assumptions
- GMC-registered medical practitioner or equivalent medical degree and accreditation.
- Minimum of four years’ clinical experience after completion of pre-registration post.
- Sub-specialty training in Pharmaceutical Medicine, or diploma in pharmaceutical medicine will be an advantage
- MRCP, MFPM, PhD or Postgraduate training in clinical epidemiology and biostatistics will be an advantage.
- Specialization or experience in, neurology.
- Our company is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases.
- Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
- Our company is one of the world’s oldest independent biotechnology companies.
- Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
- Our company is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations.
- Our international operations are based in Switzerland and we have world-class manufacturing facilities.
- We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
- All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
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