Instagram
youtube
Facebook

Serm Scientific Director

5+ years
Not Disclosed
10 Aug. 14, 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, 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 Opportunity at GSK: Site Locations in Warsaw and Bangalore

Job Purpose: We are seeking a dedicated professional to provide in-depth medical and scientific expertise in the safety evaluation and risk management of key GSK assets. This role involves ensuring the scientifically sound review and interpretation of data, managing safety issues, and making recommendations for the management and communication of safety risks in both clinical development and post-marketing settings.

The position is pivotal in supporting pharmacovigilance and benefit-risk management across GSK’s global portfolio, ensuring patient safety worldwide. If appointed as a manager, you will lead a team, offering leadership in resource management, coaching, decision-making, and fostering collaborative relationships.

Key Responsibilities:

  • Scientific/Medical Knowledge & PV Expertise:

    • Lead pharmacovigilance and risk management planning.
    • Develop strategies for safety evaluations in clinical and post-marketing settings.
    • Oversee safety components of global regulatory submissions.
    • Evaluate clinical data, literature, and make informed decisions on safety risks.
    • Prioritize tasks and maintain high performance standards.
    • Lead and influence cross-functional teams to resolve product safety issues.
  • Cross-functional Matrix Team Leadership:

    • Lead safety governance, anticipate product safety issues, and implement risk-reduction strategies.
    • Represent GSK on cross-functional clinical and project teams.
    • Participate in process initiatives to enhance adherence to regulations and efficiency.
    • Ensure compliance with policies and regulations through updates to SOPs.
    • Build strong working relationships and demonstrate leadership in matrix settings.
  • Communication & Influence:

    • Present safety recommendations to senior staff and governance committees.
    • Influence key stakeholders internally and externally.
    • Lead cross-functional process improvement teams.
    • Contribute to the development of long-term strategies for clinical programs.
    • Ensure inspection readiness and support audits.

Basic Qualifications:

  • Undergraduate degree in medical or health sciences (Graduate degree preferred).
  • Advanced experience in the Pharmaceutical or Biotech industry, specifically in Medical Affairs, Pharmacovigilance, or Drug Safety.
  • Significant experience in safety evaluation and risk management for clinical development and post-marketing.
  • Knowledge of international pharmacovigilance requirements and drug development processes.
  • Experience working in large matrix organizations.

Preferred Qualifications:

  • Advanced degree in Life Sciences or Pharmacovigilance.
  • Strong ability to influence stakeholders at all organizational levels.

Why GSK? GSK is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. We focus on vaccines, specialty and general medicines, and invest in core therapeutic areas like infectious diseases, HIV, respiratory/immunology, and oncology. At GSK, our success depends on our people, and we strive to create an environment where everyone can thrive.

GSK is an Equal Opportunity/Affirmative Action Employer, welcoming applicants from diverse backgrounds without regard to race, color, national origin, religion, sex, sexual orientation, gender identity/expression, age, disability, or veteran status.

Important Notice to Employment Agencies: GSK does not accept referrals from employment businesses/agencies without prior written authorization. Any referral without such authorization will be considered voluntary and non-binding, with no obligation for fee payment by GSK.

Please note that if you are a US Licensed Healthcare Professional or defined as such by state law, GSK may be required to report expenses related to your interview as part of US Transparency requirements. For more information, please visit GSK’s website.