Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
This role supports one or more of the following Therapeutic Areas: Oncology.
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.
Key Responsibilities:
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 (verbal, written) and Influencing (internal PV Governance and External LTs)
- 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.
- Leads cross-functional process improvement team within GSK.
Why you?
Basic Qualifications:
- PhamD/PhD for Scientist, Bachelors of Science in Life Sciences or Medical Sciences.
- Advanced experience (5+ years) 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.
Benefits:
- Health care and other insurance benefits.
- Retirement benefits.
- Paid holidays.
- Vacation.
- Paid caregiver/parental and medical leave.