 Location: Bangalore, India
Industry Type: Medical and Clinicalc
Req ID: 402006
Application Deadline: 20th October 2024
About GSK:
GSK is a global biopharma company with a mission to unite science, technology, and talent to tackle diseases and improve the health of billions. Our aim is to impact the lives of 2.5 billion people in the next decade by focusing on both disease prevention and treatment.
Job Purpose:
As the SERM Scientific Director, you will provide expert medical and scientific guidance in safety evaluation and risk management for key GSK assets in clinical development and post-marketing settings. You will oversee the scientific review of data, manage safety issues, and escalate critical concerns to senior management. Your role is essential in supporting pharmacovigilance and ensuring patient safety globally.
Key Responsibilities:
- Scientific/Medical Knowledge & PV Expertise:
- Lead Pharmacovigilance and Risk Management Planning, developing strategies for evaluating clinical issues.
- Manage the safety components of global regulatory submissions.
- Conduct expert evaluations, literature reviews, and clinical data synthesis.
- Demonstrate quality decision-making and problem resolution skills.
- Cross-Functional Matrix Team Leadership:
- Develop and execute safety strategies for products in clinical development and post-marketing.
- Facilitate safety governance and lead cross-functional teams to address product safety issues.
- Ensure adherence to regulations and quality standards through process improvement initiatives.
- Communication & Influencing:
- Present safety recommendations to senior management and represent GSK in discussions with regulatory authorities.
- Contribute to long-term strategy development for clinical programs.
- Prepare for audits and inspections, ensuring readiness and compliance.
Candidate Profile:
- Education: Health Sciences/Healthcare Professional degree (BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D; Dentists and Veterinarians also accepted).
- Experience: 4-9 years in the Pharmaceutical or Biotech industry, particularly in Medical Affairs, Pharmacovigilance, or Drug Safety.
- Expertise: Significant experience in Safety Evaluation and Risk Management, both in clinical development and post-marketing. Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP) is essential.
- Skills: Strong influencing abilities, experience in large matrix organizations, and excellent verbal/written communication skills.
Why Join GSK?
At GSK, you’ll be part of an innovative team working toward meaningful healthcare advancements. We are dedicated to providing an environment where our employees can thrive, positively impacting patient outcomes worldwide.
Application Process:
To apply for the position of SERM Scientific Director, please submit your application by 20th October 2024.
GSK is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
