Pfizer Inc. Safety Risk Lead, Director, MD in New York, New York
The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization.
- Act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety.
- Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a "Centre of Excellence".
- Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSR/SER Authors.
- Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
- Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
- Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
- Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
- Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.
- Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required.
- Prepares basic action plans independently to address risk and benefit-risk issues. Handles more advanced/complex plans with direction/coaching.
- Conducts and Represents SSRM on due diligence activities.
- Provides guidance and/or oversight to SSRM colleagues on safety issues. Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics.
- Represent WSS on safety and benefit-risk issues to external groups including regulatory authorities and business partners.
- Contributes to review and development of intradepartmental policies and procedures as appropriate.
- Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight.
- Prepares and contributes to written safety assessments and benefit-risk evaluations.
- Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues.
- Completes all assigned activities with minimal guidance.
- Makes decisions based on clinical experience.
- Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of product issues.
- Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
- Ensures products fulfill quality medical care.
(Note: "BU" used herein = BU/RU).
- Education: MD (physician) degree required
- Minimum 5 years of medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required.
- Disease Area specific knowledge is preferred.
- Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
- Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
- Demonstrated leadership in day-to- day activities and collaborative skills.
- Demonstrated self-awareness and interpersonal skills for successful execution of the role.
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
- Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
Technical Skills, (plus knowledge, experience and ability in):
- Safety data review, Safety data assessment, Clinical Safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums.
- Matrix safety team leadership
- Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities
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.
Other Job Details:
- Last Date to Apply for Job: May 1, 2018
- Additional Location Information: New York Headquarters, NY; Peapack, NJ; Collegeville, PA; Groton, CT.
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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.