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Safety Case Manager

5-7 years
Not Disclosed
10 Dec. 7, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: Safety Case Management Lead

Location: Telangana, India
Division: Sandoz
Functional Area: Research & Development
Employment Type: Full-time, Regular


Your Key Responsibilities:

You will play a pivotal role in ensuring global compliance, quality, and operational efficiency in safety case management for Sandoz Group products. Your responsibilities include but are not limited to:

Safety Case Management

  • Oversee global compliance and management of post-marketing and clinical trial safety cases.

  • Develop and maintain processes for both in-house and outsourced activities to meet regulatory requirements for safety case reporting.

  • Author, review, and update SOPs related to safety case management.

Supplier Management

  • Collaborate with strategic suppliers to review performance and identify areas for development and capability building.

Audit & Inspection Leadership

  • Lead global internal audits and Health Authority inspections, ensuring readiness and timely corrective and preventive actions.

Cross-functional Collaboration

  • Serve as a subject matter expert (SME) in safety case management for cross-functional projects, including acquisitions and mergers.

  • Represent Patient Safety in internal and external meetings with global line functions and third parties (e.g., Vigilance Agreement Partners).

Operational Excellence

  • Drive operational improvements to enhance efficiency and align with Patient Safety’s vision and objectives.

Compliance & Training

  • Ensure conformity with global procedures, processes, and regulatory requirements across the safety case management team.

  • Develop and maintain training plans for new hires, aligned with job roles and responsibilities.

Team Leadership

  • Recruit, set objectives, and manage the performance of direct reports.

  • Contribute to talent retention strategies and team development.

Continuous Improvement

  • Lead and support initiatives for quality, productivity, and innovation using internal and external resources.

Deputy Responsibilities

  • Deputize for the Head of Case Management and Aggregate Reporting when required.


What You’ll Bring to the Role:

Qualifications:

  • Experience:

    • 5–7 years in the pharmaceutical industry, preferably in pharmacovigilance.

    • 2+ years of people management and development experience is desirable.

  • Knowledge:

    • Strong understanding of drug safety regulatory requirements.

    • General project management expertise is advantageous.

Skills:

  • Excellent negotiation, conflict resolution, decision-making, and problem-solving skills.

  • Strong written and verbal communication and presentation abilities.

  • Results-driven, self-starter with a proactive working style.

  • Transparency and accountability, even under pressure.


Why Join Sandoz?

About Sandoz:

Sandoz is a leader in the generic and biosimilar medicines sector, touching the lives of nearly 500 million patients annually. With ongoing investments in innovation, partnerships, and state-of-the-art production, Sandoz is committed to expanding access to affordable, high-quality medicines.

Our Culture:

We foster a collaborative, agile, and inclusive environment that encourages personal growth. At Sandoz, diversity is celebrated, and we believe in shaping a future where both employees and patients thrive.


Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment with diverse teams that reflect the communities we serve.


Division: Sandoz
Business Unit: Sandoz
Site: Telangana (Sandoz)
Job Type: Full-time
Shift Work: No

The future is ours to shape—join us in making a difference!