• GlaxoSmithKline PLC
  • $81,640.00 -118,940.00/year*
  • Drexel Hill , PA
  • Engineering
  • Full-Time
  • 759 Cornell Ave

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
  • activities
  • 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
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements. For more information, please visit GSK s Transparency Reporting For the Record site.


    Associated topics: bio, bioengineering, biology, biomedical engineer, biophysics, bioprocess, bioprocessing, msat, nutrition, pharmaceutical

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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