Safety Evaluation Risk Management SERM Associate Medical Director Vaccines

You will need to login before you can apply for a job. Safety, Evaluation advises on content of regulatory period reports (in partnership with the product physician).Author the SERM safety contribution to global regulatory submissions in partnership with the product physician.May respond to auditors/inspectors requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.Make 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.Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.Cross

-functional Matrix team leadershipSupport 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 ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.Build strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes.

Ability to coach and mentor others.Communications (verbal, written) and Influencing (internal PV Governance and External LTs)Present complex issues to senior staff members at the GSK Senior Governance Committees.Demonstrate initiative and creativity in performing tasks and responsibilities.

Proactively contribute ideas to improve existing operations.Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation.Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team.

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.Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.

veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.Substantial experience in pharmacovigilance or drug development.Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.Experience working in large matrix organizations.

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