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Senior Director TA Head Safety, PEH (ID, Hem/Onc, Biosimilar, Injectables)


Peapack and Gladstone, NJ
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Job Details

The primary objective of the Therapeutic Area Head (TAH) is to contribute to the surveillance of the safety profiles of Pfizer products, both under development and marketed, for one or many therapeutic areas, by taking responsibility for the efficient and appropriate evaluation and aggregate review of all adverse events and at risk reports received by Pfizer within his/her TA, including specific relevant medical documentation. The TAH has management responsibility for all members of the Therapeutic Area team, wherever they may be sited (global virtual team management). This is an above country function. Therapeutic Areas are expected to range in size of up to 25 colleagues. Areas managed include: Medical Review, as well as medical review of Aggregate Reports and other medical documents delivered by SER. The TAH is responsible for leading, maintaining and fostering portfolio product expertise within SER.

+ Establish the goals, and manage the day-to-day performance, of the medical review team responsible for safety evaluation within the assigned therapeutic areas

+ Responsible for the safety portion of acquisitions, divestitures and in-license deals

+ Responsible for the quality and compliance to all regulators including FDA, EMA, PMDA, MHRA and other competent authorities for areas under their purview in collaboration with the SER CoEs.

+ Direct medical review activities, in accordance with regulations and Pfizer Standard Operating Procedures and associated documents, using assigned resources to meet compliance requirements and performance targets for quality and timeliness

+ Responsible for identifying and driving process improvement/continuous improvement around areas of direct responsibility including Medical Review

+ Participates in appropriate committees including Risk Management Committees and Labeling teams

+ Responsible for ensuring the Therapeutic Area is following all applicable regulations

+ Facilitate effective communication within the team, with other Safety colleagues and with internal and external stakeholders, to assure that all issues are effectively surfaced for resolution

+ Contribute to the review and endorsement of Customer Engagement Programs designed by marketing and medical in collaboration with SER Business Management. Point of contact for internal customers with respect to any Customer Engagement Program in their area

+ Ability to represent Therapeutic Area for all areas of responsibility for depositions and other legal interactions

+ Provide professional leadership and support to Therapeutic Team Members, when required

+ Lead, maintain and foster portfolio product expertise through collating appropriate information from internal and external sources, evaluate for application within SER and update product reference guides in collaboration with the SER CoEs. Disseminate product expertise and train product specialists and generalists.

+ Point of contact for SSRM cluster leads


+ Must be a physician by training. Minimum two years clinical practice, with MD certification preferred

+ Minimum five years' experience in Pharmacovigilance, clinical research or related experience

+ Experience in managing physicians responsible for single case processing and multidisciplinary, matrix teams

**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.

**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.

**Other Job Details:**

+ 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.
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