The Safety Team Lead will make active contributions to activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements. Backup contact point in the country, internally and externally, for all safety-related aspects. Supports resource management in the country.
This colleague will Support the CSL in fulfilling drug safety-related obligations for the country and participate in above-country activities as DSU representative, as required by CSL. Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country. In collaboration with the CSL, ensure timely handling of local safety issues, manage local safety issues in collaboration with central safety functions and relevant stakeholders, as required and support the timely handling of local safety-related regulatory requests.
Role Responsibilities
• Maintain expertise in country as well as worldwide regulations and guidelines
• Promote increased awareness of the legislative and regulatory environment in the country
• Deputise for the CSL, as requested, in the promotion of local, internal and external safety
• activities, in collaboration with the relevant stakeholders
• Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities, as required by local agency, and any other required country-specific safety activity
• Support the CSL in organizing and managing the country safety group to ensure effective coverage of safety-related activities
• Develop and maintain knowledge of applicable SOPs and other procedural documentation
• Provide guidance for standardization of processes and goals
• Manage and monitor the effective rollout of new processes
• Facilitate resolution of concerns and questions
• Mentor colleagues on the effective use of the corporate safety database
• Support the organization and management of inspection readiness activities
• Support the implementation of corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country
• Support the standardization and quality of safety data exchange agreements
• In collaboration with the CSL, monitor and manage training of DSU members, and ensure coaching and mentoring
• Support effective recruitment for the DSU; fully utilize corporate tools to manage the performance reviews of assigned colleagues in the country
Qualifications
• BA Degree in medicine or in life sciences and 14+ years of of pharmaceutical industry experience in pharmacovigilance or clinical research or product development required
• MA and 12+ or PhD and 9+ years of experience preferred
• 1+ years of experience in people management required
• Minimum 5 years experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required Experience and skill with medical writing an advantage
• Good understanding of computer technology, and management of relational database systems
• Demonstrated computer literacy, particularly in the use and management of relational databases
• Excellent knowledge of national and international regulations
• Excellent oral and written communication skills and fluency in spoken and written English
• Good understanding of medical and scientific terminology
• Knowledge of pharmacovigilance reporting requirements
• Rational approach to issues and their business implications
• Demonstrated problem solving and decision-making and negotiation skills
• Team building and team management skills
• Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
• Highly skilled in time management and change management, organizational and facilitation skills
• Ability to meet personal objectives while meeting departmental standards of performance
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.
Medical
Job Type: Full time