Are you energized by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this Safety Pharmacovigilance Director role could be an ideal opportunity to explore.
S afety Governance and Risk Management activities
Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit- Risk Management Plans for designated products
Leads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
Delivers the clinical safety input into clinical development planning activities
Represents SMG on cross functional Clinical Matrix Teams and/or Project Teams.
Leads cross-functional ad hoc
teams to address urgent and important product safety issues
Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
May lead or participate in discussion at Global Safety Board for safety related findings in clinical development.
Presents safety information at clinical investigator and commercial meetings. Ensures prompt notification to Pharma Safety Head of reviewed protocols that are identified as potential PASS
Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues.
Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the Pharma Safety Head .
Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
S ignal Detection, Evaluation and Labelling
Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
Makes recommendations to Pharma SafetyTeam Leader for the assessment and prioritisation of safety signals
Proactively leads the assessment of safety data and discusses the results with the Pharma Safety Team Leader/ product physician and safety scientist
Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
Produces regulatory supporting documentation for labelling updates
Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet
Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints
In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion
Regulatory Reports and Submissions
Drives production of periodic regulatory documents (PBRERs, DSURs) according to the agreed process and timelines.
Advises on strategy for the content of high profile PBRERs
Supports the Local Operating Companies by preparing license renewal documentation (e.g. PBRER addenda line listings, clinical overviews, summary bridging reports) as required for each market
Leads the Pharma Safetysafety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Ot her Pharma Safety A ctivities
Drives the review or production of the Pharma Safety component of Safety Data Exchange Agreements and escalates any deficiencies to the Pharma Safety Head to ensure quality and integrity of agreement.
Advises on the preparation of licensing agreements in therapeutic area of responsibility
Participates in due diligence activities by providing expert safety assessments and recommendations
Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
Provides support to GSK Legal for product liability litigation, as appropriate
Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
Leads a process improvement initiative within SMG.
Contributes to advancement of methodology and process by generating new ideas and proposals for implementation
Raises concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner
Trains, coaches and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
E DUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE
Bachelors Degree in Biomedical or Health Care related speciality and a minimum of 2+ years of previous safety experience in the pharmaceutical space
Prior clinical experience preferred
Oncology experience preferred
Prior experience in pharmaceutical industry, preferably pharmacovigilance, preferred
Expert evaluation skills and analytical thinking
Outstanding medical writing skills
Sound computing skills
Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety
Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
Sound knowledge of the therapeutic area of assigned GSK products
Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
Clear understanding of clinical development process
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