Job Description Summary-Designs and develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams.
Job DescriptionSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' Sandoz!
Your Key Responsibilities:Your responsibilities include, but not limited to:
- Drive staff development in support of SDZ products
- Uses expertise and knowledge of global issues to develop strategic Physicians and staff objectives for inclusion into business objectives.
- Performance appraisals including objective setting, mid-year and annual performance evaluation, career development and other management issues for medical function team members
- Contributing to overall training of Medical Safety physicians, including medical, scientific and safety training and sharing of best practices.
- Contributes to ensuring that an adequate number of qualified physicians and staff is available for Medical Safety & Medical Safety Operations to satisfy SDZs objectives in the Patient Safety area
- Ensures that own work and work of team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
- Portfolio-level accountability for quality including review of key deliverables (eg RMPs and PSURs) as applicable, and adherence to PV regulations
- Chair MSRB on EUQPPV request
- Accountable for the delivery of high quality, timely and standardized Medical Safety deliverables across Medical Safety. Provides content guidance and Line Function approval as needed for safety documentation prepared by the Medical Safety associates within Medical Safety
- Establishes and maintains common global processes and guidelines for Medical Safety assessment, analysis, and compliance within Medical Safety, including documented guidance for coding and the assessment of causality/expectedness for adverse event.
- reports as required
- Ensures that Medical Safety signals from aggregate data are identified promptly and
- communicated/escalated appropriately, including oversight (as appropriate) of ESP
- Maintains a close collaboration with the EU QPPV by proactively escalating potential safety issues / changes that affect the Benefit-Risk profile of the assigned product portfolio to
- the EU QPPV. Reviews PSURs and RMPs on behalf of QPPV as a delegated activity when
- required
- Initiates and maintains productive cross-functional Medical Safety collaborations with
- colleagues within PS and those from other functions, e.g. Clinical Development,
- Medical Affairs, Regulatory Affairs, Medical Information, Clinical Pharmacology, QA, as well as externally with ESP, expert panels, and other scientific contacts
- Represents Sandoz medical safety at outside organizations like Medicines for Europe, CIOMS, PhRMA as required
- Identifies external consultants on safety issues, as appropriate, when internal resources may be insufficient or when third party advice is desirable.
- Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities. Ensure appropriate in-licensing safety evaluation and alignment.
- Promotes operational excellence and process simplification
- Deputize for the Global Head Patient Safety as required for specific activities
- As a member of the Patient Safety Leadership team, contribute to successful functioning and health of the PV system
- Managing the travels & accommodations and the training budgets of medical Function
What you'll bring to the role:Essential Requirements:
- Management experience (2- 10 direct reports)
- Medical Degree, preferably with board-certified specialty. Useful additional degrees: Post-graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
- Required experience (12-15 years)
- At least 2 years in clinical/hospital practice
- At least 10 years in drug development in a major pharmaceutical company or CRO (of which 7 years in a global position), including 7 years in safety at an operational oк medical position
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
- Experience in responsible/leading roles in clinical or safety through complete submission process
- Experience in presenting clinical or safety data to major Health Authorities
- Strong leadership skills including coaching, motivating, and directing, and fostering teamwork
- Ability to develop and maintain effective working relationships with subordinates, superiors and peers
- Strong negotiation and conflict management skills
- Experience in leading cross-functional, multi-cultural teams
- Experience with safety (or other) issue management
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
- Management experience (2- 10 direct reports)
You'll receive:Sandoz has an employee-first approach and that's why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.
In addition to the various learning opportunities, we offer company benefits, such as:
- 30 days of annual leave
- Holiday allowance
- Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
- Company pension schemes and capital formation benefits
- Parental leave
- Other offerings, such as bike leasing
Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Sandoz Network:If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz Skills DesiredCross Functional Teams, Leadership, Medical Strategy, Multi Cultural Team Leadership, Process Safety Management, Regulatory Compliance, Safety Science, Strategy
