- Provide pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians
- Represent pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams.
- Lead signal detection/safety monitoring activities for pharmacovigilance operations.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
- Ability to perform case report QC, review, follow-up and reportability assessments.
- Liaise with other relevant functional areas within TGRD, TPC and external parties to provide input on safety data collection, analyses, and risk management.
- Represent pharmacovigilance department in cross-functional teams or committees and external environments that have global study or program impact.
- In depth knowledge and understanding of designated products/studies.
- Participate as Pharmacovigilance expert in the Global Safety Teams for designated products.
- Work closely with Global Safety Lead on all aspects of signal detection/safety review activities.
- Perform advanced searches in the safety database to retrieve requested safety data.
- Active participation in internal and cross functional Task Forces
- Project support activities for designated developmental products include:
- Master working knowledge of regional protocols to effectively respond to safety issues.
- Provide investigator and monitor training on safety procedures
- Compile and write IND update/ACSR documents
- Assist in set up of safety procedures and contribute to development of safety exchange agreements for co-development projects
- Develop department templates for clinical and post-marketing projects
- Compile, write and review monthly safety reports
- Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
- Assist with writing and maintenance of the Safety Monitoring Plan
- Assist with set-up and running of DSMBs
- Project support activities for designated marketed products
- Write, compile, and review of PSURs
- Review of monthly safety reports
- Assist in set up of safety procedures and contribute to development of safety exchange agreements for co-marketing projects
- Develop department templates for post-marketing projects
- Assist with writing and maintenance of the Risk Management Plan
- US only activities include:
- Creation of FDA periodic reports
- Training of marketing and sales force in safety related topics
- Review and provide input into documentation related to investigator sponsored studies
- Liaison for internal commercial operations team (Commercial Product Quality, Medical Information, Medical Affairs) and external call center providers.
- Review and provide input into documentation related to marketing studies (e.g., Registries)
- Liaison and training of call-centre providers.
- Identify, plan, and execute improvement of departmental processes.
- Any other tasks assigned by manager to assist in departmental activities.
- Registered Nurse or Bachelors degree required; scientific/medical field preferred
- Minimum 4 years healthcare, clinical or pharmacovigilance related experience including a minimum of 2 years in clinical monitoring, safety or Pharmacovigilance.
- Excellent databases and coding skills including ability to perform advanced searches
- In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
- Critical thinking and decision making skills
- Ability to review, analyze, interpret and present complex data to a high standard
- Understanding of Takeda business needs with global business perspective and professional attitude.
- Good level of computer literacy with Microsoft applications
- Excellent organization skills and ability to prioritize
- Excellent written and oral communication skills including ability to present to large internal/external groups.
Estimated 5-10 times per year including possible international travel.
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We are an equal opportunity employer.
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