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    Serm Scientific Director

    Gsk Plc
    7+ years
    Not Disclosed
    Bangalore
    10 Oct. 16, 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 Description: Pharmacovigilance Expert

    Locations: Warsaw, Bangalore, Poznan Grunwaldzka, Poznan Pastelowa
    Posted Date: September 26, 2024

    Job Purpose
    As a key contributor to GSK, you will provide in-depth medical and scientific expertise in the safety evaluation and risk management of our global assets. You will ensure scientifically sound reviews and interpretations of safety data, escalating any safety issues to senior management and safety governance as necessary. Your recommendations will help characterize, manage, and communicate safety risks, ultimately supporting the pharmacovigilance and benefit-risk management of our portfolio to ensure patient safety worldwide.

    If appointed as a manager (Team/Group Leader), you will lead a team of individual contributors, utilizing competencies in resource management, coaching, and collaborative decision-making.

    Key Responsibilities

    • Scientific/Medical Knowledge & PV Expertise:

      • Lead pharmacovigilance and risk management planning, developing strategies for evaluating clinical issues.
      • Oversee safety components of global regulatory submissions.
      • Apply expert evaluation and analytical skills for literature review and clinical data synthesis.
      • Make quality decisions and resolve problems creatively, considering all relevant information.
      • Demonstrate strong multi-tasking abilities, prioritize effectively, and deliver high-quality results consistently.

    • Cross-Functional Matrix Team Leadership:

      • Develop and execute safety strategies for clinical development and post-marketing products.
      • Facilitate safety governance by establishing and operating cross-functional teams to address product safety issues.
      • Represent GS on clinical matrix teams and lead ad hoc teams for urgent safety concerns.
      • Author and update standards (e.g., SOPs) to ensure compliance with regulations.
      • Build strong relationships and display leadership skills within a matrix setting.

    • Communication and Influencing:

      • Present recommendations and safety issues to senior governance committees, confidently interacting at all levels.
      • Lead cross-functional process improvement initiatives and contribute innovative ideas to enhance operations.
      • Ensure inspection readiness and support audits/inspections as needed.

    Basic Qualifications:
    We are looking for professionals with the following skills:

    • Degree in Health Sciences/Healthcare (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists, or Veterinarians).
    • Advanced experience in the pharmaceutical or biotech industry in medical affairs, pharmacovigilance, or drug safety.
    • Significant pharmacovigilance experience in safety evaluation and risk management in both clinical development and post-marketing activities.
    • Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP modules) and drug development processes.
    • Experience working in large matrix organizations.

    Preferred Qualifications:

    • Advanced Degree in Life Sciences or Pharmacovigilance.
    • Ability to influence key stakeholders at all organizational levels.

    Why GSK?
    GSK is a global biopharma company with a purpose: to unite science, technology, and talent to combat disease and enhance global health. We focus on vaccines and innovative medicines in key therapeutic areas, including infectious diseases, HIV, respiratory/immunology, and oncology.

    At GSK, we aim to create an inclusive environment where everyone can thrive, feel valued, and grow professionally. Join us in our mission to make a positive impact on the health of billions.

    Equal Opportunity Employer:
    GSK is an Equal Opportunity/Affirmative Action Employer. We encourage applications from all qualified individuals without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, veteran status, or any other protected class.

    Important Notice:
    GSK does not accept referrals from employment businesses and agencies. Prior written authorization is required for any referrals.

    For more details, visit GSK Careers.

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    Warsaw |

    Remote :

    Bishop | Hammond | Riga | Xzagreb | Slovakia | Victoria | Lousiana | Melbourne | Tulsa | Green Way | Thailand | Switzerland | Remote - Africa | Belgium | Blue Bell | Texas | Hungary | Minnesota | Remote | Ireland | Remote - South America (Latin Americal) | Castlebar | Leinster | Remote, USA | Remote - Europe | Remote - Middle East | French | McFarland | Nairobi | Lenexa | Medan | Manipal | Faridabad | Zaragoza | Bountiful | Springville |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Najran | King Abdullah Economic City | Jeddah | Riyadh | Khulais |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |