SERM Associate Medical Director

Responsibilities

• Be responsible for signal detection and evaluation activities for assigned products.
• Do advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation, while making sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems.
• Be committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully with appropriate attention to detail, setting high performance standards for quality.
• Support and facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross functional teams in any SERM to detect and address product safety issues and ensure that risk reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Build strong collaborative relationships and demonstrate good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
• Possess effective communication skills and be capable of presenting ideas and data clearly and concisely to a matrix team and senior staff members at the GSK Senior Governance Committees. Listen and respond appropriately to the views and feedback of others.
• Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.

Basic Qualifications

• Advanced degree in a relevant discipline, (MD, DO or MBBS)
• Demonstrate ability to apply medical and scientific knowledge to evaluate and interpret safety information
• Strong analytical and critical thinking skills with ability to review, interpret scientific/medical literature, and make sound medical judgments based on available clinical and scientific data
• Strong organizational skills with the ability to manage multiple priorities in a fast paced environment
• Demonstrate ability to learn quickly, adapt to a new process, and/or develop expertise in pharmacovigilance practices and safety regulations
• Be a Team Player

Preferred Qualifications

• Additional relevant medical or scientific post graduate qualifications (e.g. PhD in life science; candidates with strong transferable skills such as ability to critically evaluate clinical and safety data, possesses sound medical/scientific judgement and ability to perform safety assessment are encouraged to apply)
• Prior experience in pharmacovigilance, drug safety, safety evaluation and risk management, benefit risk evaluation, aggregate safety reports, clinical development and/or post marketing activities or related field
• Familiarity with global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA)
• Background in clinical research, epidemiology, or regulatory science
• Demonstrate ability to contribute to safety strategy, risk management activities and cross functional safety discussions
• Experience working in large matrix organisations

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.