Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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!