Job Description
The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:
Case review/approval for assigned products
Expedited case submission according to timelines outlined in applicable regulations
Case entry for non-PV-Works countries for assigned products
Aggregate report preparation and submission to National Teams or Competent Authorities according to timelines outlined in applicable regulations
Support national PV teams as applicable
Product expert for assigned products
Provide qualified answers to questions raised by internal or external stakeholders (e.g., Competent Authorities) for products for which the Senior Specialist is responsible
PV Statement preparation in compliance with relevant regulations, policies, and procedures
Same/similar designation of assigned products
Allocation of new product activated in PV-Works to the applicable product family
Risk management for assigned products
Participation in signal management activities, including (but not limited to) signal detection, prioritization, validation, assessment, and recommendation for action
Signal management statement preparation and, if applicable, submission to Competent Authorities according to timelines outlined in applicable regulations
Analysis of peer-reviewed literature
Review of clinical study data
Participation in risk communication planning
Participation in the design and/or fulfillment of supplementary monitoring activities
Development of risk minimization strategies
Archive all relevant documents/communications as agreed or defined in the applicable procedures
Additional activities may include at least one of the following:
Participation in team meetings
Participation in audits/inspections as applicable
Support CAPA completion activities as applicable
Support GPV procedure management
Support training
Provide business support for pharmacovigilance database systems (e.g., review validation documents and execute User Acceptance Tests (UATs) for functionality changes)
Perform literature searches
Function as Content Lead for one or more GPV sub-teams (e.g., training, risk management, procedure management):
Establish team priorities and allocate resources accordingly
Provide oversight of team projects/activities, including tracking progress and compliance with projected timelines
Facilitate group meetings
Manage team questions and engage in problem solving to address concerns as they arise
Consult PVLT for guidance and feedback on team activities as needed
Participation in projects as agreed with the manager
This position is based at our Rahway, NJ facility with a hybrid work schedule.
DESIRED QUALIFICATIONS:
Knowledge of regulations governing pharmacovigilance for veterinary medicines
Experience with PV databases
Strong analytical, communication, and writing skills
Experience with biostatistics and epidemiological principles
Animal Health/Animal Science background is highly preferred
ACADEMIC REQUIREMENTS: any of:
DVM or PhD in a clinically/scientifically relevant field
MS or equivalent in a clinically/scientifically relevant field with 3 years of experience in a highly regulated pharmaceutical field
BA/BS or equivalent in a clinically/scientifically relevant field with 5 years of experience in a highly regulated pharmaceutical field
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$114,700.00 - $180,500.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
03/17/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
