Job Description

ABOUT CLINCHOICE

ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally.

 SUMMARY

The Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Janssen products and will strategically lead cross-functional teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as a product spokesperson regarding overall benefit/risk. 

The MSO will report to the Therapeutic Area (TA) Safety Head for Immunology and lead all aspects of the safety and benefit/risk assessment of assigned pharmaceutical products that are marketed and/or in clinical development within the Immunology TA. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of their products relative to their potential benefit to patients. The MSO will be the primary point of contact for safety concerning his/her assigned products and clinical programs, and will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. 

This role requires leadership of cross-functional Safety Management Teams (SMT) for assigned products or clinical programs, with key responsibilities including, but not limited to, signal detection, benefit/risk assessment and risk management activities (e.g. label updates, urgent safety measures). Other responsibilities include participating in strategic planning of clinical protocols and development programs and patient-centered decision-making, as well as ownership of aggregate reports (PBRER/PSUR). The Medical Safety Officer will present (either orally or in writing) the Company's scientific position with regard to safety in support of regulatory filings or in response to Health Authority requests. The MSO will be an integral member of due diligence teams, and have a seat at the table for go/no-go decisions on Licensing and Acquisition opportunities within the Immunology portfolio.

This role relies upon strong foundational knowledge in medicine as well as the ability to engage, influence, and mobilize teams.

QUALIFICATIONS - EXTERNAL

• Physician (MD or equivalent) with 6-9 years related experience as defined by the following:

Requires at least 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research in pharmaceutical industry or academic setting)

Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience, which includes a residency program or equivalent)

• Board Certification (if US) preferred 
• Basic knowledge of drug development, pharmacology, clinical trial methodology and design, and assessment of drug benefits vs. risks is a must. Knowledge of biostatistics and epidemiology is preferred 
• Experience with structured benefit-risk frameworks (e.g. BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development is a plus.
• Ability to influence, negotiate and communicate with both internal and external stakeholders 
• Experience with formal Health Authority presentations is preferred. 
•  Ability to see the context of the entire situation, understand implications to the business.
• Ability to critically evaluate safety data from multiple sources (clinical trials, post-marketing, and literature, etc.)
• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
• Excellent writing skills as evidenced by publication and journal articles also desirable
• Proficiency in Word and PowerPoint is desired

CLINCHOICE IS AN EQUAL OPPORTUNITY EMPLOYER / COMMITTED TO DIVERSITY