Safety Strategy Lead

Employer
Docs Global (Continental Europe)
Location
Germany
Salary
Competitive
Closing date
21 Sep 2020

View more

Discipline
Operations, Health and Safety
Hours
Full Time
Contract Type
Permanent
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Safety Strategy Lead ,
Global Patient Safety, Medical Safety Therapeutic Area (TA)
Germany, (m/f/d)

Contact DOCS: Roger Bravo
Konrad-Zuse-Platz 11
81829 München
+49 (0) 175 268 7114
roger.bravomendez@docsglobal.com

Summary:

For a multinational biopharmaceutical company DOCS is hiring a Safety Strategy Lead (m/f/d). If you want to develop further into your career in the pharmaceutical industry and by doing so helping to improve treatment of today's biggest challenges to public health, than this might be for you.

Role and Responsibilities:

The role of the GPS Safety Strategy Lead is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management.

• set the medical safety strategic direction, in the context of delivering the benefit-risk profile, and provide clear, strong and visible safety scientific leadership, in partnership with R&D cross-functions
• ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management throughout the lifecycle of the product
• ensure that safety signals are identified promptly and communicated/escalated within the company appropriately
• ensure high quality medical safety contributions to Pharmacovigilance Advisory Board (PVAB)
• develop and leverage medical safety strategic contributions to other R&D governance bodies and review committees (e.g. DSC, MSEB, GMDB)
• represent GPS on cross-functional teams for the product, including e.g. the Global Program Team (GPT) and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met
• represent GPS at submission teams and provide safety strategic input into submission documents such as Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports
• chair the BRAT and SMCs as required
• represent GPS on safety aspects for the product externally, e.g. engagement with external SMC/IDMC members
• preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
• act as a subject-matter expert on medical safety in interactions/discussion/negotiations with regulatory authorities
• ensure effective communication of product-related aspects in audits and regulatory authority inspections
• provide medical safety expertise for due diligence activities as required
• provide efficient oversight for medical safety activities in support of outsourcing and offshoring models
• maintain a profound level of knowledge about the product and the therapeutic area
• provide product- or TA-specific training to GPS colleagues, and safety training to non-safety colleagues, as required
• coach, support and help develop other GPS staff in relevant GPS Product Teams

What is required:

Required professional experience and necessary training

• Physician with broad clinical experience; alternatively science or other healthcare related doctoral degree

• Fluent in written and spoken English

Necessary professional experience
• Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area
• Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s
• Excellent knowledge of product development process and experience of cross-functional teamwork
• Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
• First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
• Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics
Professional experience in a global matrix environment across regions

What is offered for this position:

• Competitive salary
• Permanent contract with DOCS
• Full time, fully home based or office based
• Long term perspective
• Chance to work with a very successful pharma sponsor

Why this vacancy is right for you:

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

At DOCS , our people are our greatest asset.

Our primary focus is on the acquisition, management and development of the best candidates in the drug development industry so that they can continue to drive the success of the business and meet the individual needs of our customers.

The DOCS leadership is comprised of key influencers and industry experts, bringing years of experience to the company.

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that have a direct impact on the health and quality of life of the patients.

Interested? Please submit your CV to roger.bravomendez@docsglobal.com or call me on +49 (0) 175 268 7114. We are looking forward to receiving your application.

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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