POSITION PURPOSEPfizer's US Drug Safety Unit (DSU) is excited to announce an opening for a Safety Team Lead. The successful candidate will be an active contributor to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer's products and to meet regulatory requirements. She/He will also be a back-up contact point in the country, internally and externally, for all safety-related aspects as well as support in-country resource management. Other key responsibilities outlined below.PRIMARY RESPONSIBILITIES
Support the Country Safety Lead (CSL) in fulfilling of drug safety-related obligations for the country
Participate in above countries 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 the local Medical Director/BU colleagues, as required
Support the timely handling of local safety-related regulatory requests
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 Medical Director and BU colleagues.
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 US-FDA and any other required US 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, 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
TECHNICAL SKILL REQUIREMENTS
Good understanding of medical and scientific terminology
Knowledge of pharmacovigilance reporting requirements
Rational approach to issues, and their business implications
Good problem solving and decision making skills
Team building and team management skills
Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
Excellent communication and negotiation skills
Good oral and written communication
Highly skilled in time management and change management, organizational and facilitation skills
Ability to meet personal objectives while meeting departmental standards of performance
QUALIFICATIONSBASIC QUALIFICATIONS
Bachelor's Degree in health or life sciences required
Minimum 5 years' experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required
Minimum 3 years' experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development
1+ years of experience in people management preferred
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
Fluency in spoken and written English
PREFERRED QUALIFICATIONS
Advanced degree and Health Care Professional (HCP) preferred
Experience and skill with medical writing an advantage
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Job Location: On premise with relocation assistance availableThe annual base salary for this position ranges from $118,100.00 to $196,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies to the Tampa, FL location only. The salary range provided does not apply to any other United States location or locations outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 EligibilityPfizer 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. This position requires permanent work authorization in the United States.Medical
