Job Description
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
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 (preferred)
- 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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement•
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 salary range for this role is
$114,700.00 - $180,500.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Required Skills: Adaptability, Animal Science, Auditing, Business Management, Communication, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Management Process, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance, Regulatory Reporting, Risk Communications, Risk Management, Risk Minimization, Training and Development, Veterinary Epidemiology, Veterinary Medicine, Veterinary Products
-Preferred Skills: Job Posting End Date: 09/2/2025
*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. Requisition ID: R362167
Job Tags
Full time, For contractors, Work at office, Local area, Remote work, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,