SERM Scientific Director, HIV

The SERM Scientific Director, HIV will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.

Responsibilities include:

Scientific/Medical Knowledge PV Expertise

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem resolution.
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines.

Cross-functional Matrix Team Leadership

• Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings.
• Facilitates safety governance/SRTs in the clinical development and post marketing settings.
• Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams.
• Leads or participates in cross-functional process initiatives and/or Process Workstreams.

Communications and Influencing

• Leads presentations on recommendations or safety issues to senior staff members.
• Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation.
• Excellent communication (verbal, written) and influencing (internally and externally) skills.

Requirements

• PhamD or PhD required
• Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management
• Experience with Signal Detection and safety surveillance
• Knowledge/experience of international pharmacovigilance requirements and drug development and approval processes.
• Experience working in large matrix organizations