Overview
Job Purpose
This position supports, for example, one or more of the following Therapeutic Areas: Respiratory, Infectious Diseases/HIV, Hepatitis/Fibrosis, Neurology/Dementias.
Provides 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.
Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.
Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Key Responsibilities
* 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, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
* Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
* Explores positions and alternatives to reach mutually beneficial agreements and solutions.
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. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
* Facilitates 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.
* Represents GSK on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
* Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
* Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
* Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
* Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.
Communications and Influencing
* Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Interacts with confidence, credibility, and influence at all levels of the organization, and represents GSK in safety discussions with regulatory authorities, outside consultants and licensing partners.
* Leads cross-functional process improvement teams within GSK. Considers the external environment when addressing safety issues and changes to processes or business improvements. Contributes to long-term strategy for clinical programs and brings innovative ideas to address new issues.
* Leads inspection readiness and is prepared to support audits/inspections.
* Excellent communication (verbal, written) and influencing skills.
Qualifications
* Medical degree (for Medical Director) or PhD/PharmD for Scientist
* Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance or Drug Safety
* Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, across clinical development and post-marketing activities
* Experience with Signal Detection and safety surveillance
* Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS) and drug development and approval processes
* Experience working in large matrix organizations
Why GSK?
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We strive to drive innovation in specialty medicines and vaccines.
We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture is rooted in being ambitious for patients, accountable for impact and doing the right thing—together, we deliver for patients, shareholders and our people.
Equal Opportunity
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants 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, military service or any basis prohibited under federal, state or local law.
Accessibility
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. If you require any adjustments to our process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available 8.30am–12.00 noon Monday to Friday.
Please note that adjustments inquiries only; other questions may be answered via our UK Recruitment FAQ guide in the Careers section.
Important notice
GSK does not accept referrals from employment agencies. All agencies must obtain prior written authorization before referring candidates.
For US-related disclosures, GSK may report expenses to comply with federal and state transparency requirements. More information is available at the CMS Open Payments data site.
Seniority level: Director
Employment type: Full-time
Job function: Research, Analyst, and Information Technology | Industries: Pharmaceutical Manufacturing
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