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Pharmacovigilance Capability And Training Subject Matter Expert (Sme)

3-5 years
Not Disclosed
15 June 13, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  •   Supports the development of Sandoz patient safety training objectives and successful implementation.  Translate business performance gaps into learning solutions, including support of quality improvement initiatives and identification of metrics.

  •  Collaborate with Subject Matter Experts (SMEs) and Process Owners to provide learning and educational programs to improve functional competencies.

  •  Collaborate across line functions within PS, including local affiliates, to ensure training needs are met and documented. Develop and maintain core training roles and curriculums for each line function with patient safety.

  •  Maintain training inspection readiness and provide direct support during all audits and Health Authority inspections.

  •  Translate business performance gaps into learning solutions, including support of quality improvement initiatives.

  •  Act as training point of contact for strategic suppliers including establishment of training programs, mechanism for training delivery and training compliance oversight paradigms

  •  Collaborate with other Sandoz learning organizations and site teams to ensure onboarding excellence.

  •   Development of strategies to assure consistent global training deployment and documentation. Production of required gap analyses reports to facilitate managerial oversight of team training compliance. Act as learning management system super user. Support other departmental activities as required.

 

What you’ll bring to the role:

Essential Requirements:

  • Three to five years of pharmacovigilance experience desired (not mandatory), including clinical safety, and closely related areas of development.

  • Proven ability to work and handle multiple tasks independently and effectively

    ·     Robust presentation and instructional design skills.

    ·     Ability to multi-task and strong organizational skills required.

    ·     Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.

    ·     Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.

    Excellent planning, organizational and computer skills

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 (hard coded in Brassring):

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:  Sandoz Talentpool (novartis.com)