Safety Physicians / Medical Directors - Drug Development
Collegeville, PA; or Research Triangle Park, NC... , PA, USA
November 26, 2019
Corporate (Biotech or Pharmaceutical)
November 26, 2019-January 26, 2020
Safety 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, and prepares the regional Risk Management Plans for designated products for submission to regulatory authorities.
- Delivers the clinical safety input into clinical development planning activities.
- 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.
- Escalates safety signals identified through the Safety Review Process to Global Safety Board.
Signal Detection, Evaluation and Labeling:
- Drives signal detection for assigned products using available methodologies.
- Proactively leads the assessment of safety data.
- Leads presentations on labeling recommendations.
- Produces regulatory supporting documentation for labeling updates.
- Provides medical sign-off for regulatory documentation.
Regulatory Reports and Submissions:
- Drives production of periodic regulatory documents (PBRERs, Annual Reports).
- 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
Accountable for medical input, review and sign-off of periodic reports (e.g. PBRERs) and renewal documentation submitted to regulatory agencies.
- Physician (M.D. or equivalent) ideally with board certification in Internal Medicine, Family Medicine, Emergency Medicine or Surgery. Subspecialty training/certification is a plus. Active or eligibility for a US Medical license is required.
- Expert evaluation skills and analytical thinking.
- Outstanding medical writing skills.
- Previous experience in clinical practice.
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety activities.
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education.
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
About the Employer
GSK Oncology has a strong commitment to the discovery and development of new innovative therapies for patients suffering from hematological malignancies or solid tumors, specifically in four cutting-edge areas of research: Cancer Epigenetics, Immuno-Oncology, Cell & Gene Therapies, and Synthetic Lethality.
1250 South Collegeville Road
Collegeville, PA 19426 USA
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