Specialist, Drug Safety
Specialist, Drug Safety
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$ 85600 - 134800
1 Vacancy
Job Description
Job Description
About the role:
We are seeking a detail-oriented Pharmacovigilance Specialist to support our global PV team. The successful candidate will participate in case processing and reporting support aggregate reporting and risk management activities help maintain PV databases and documentation and provide general administrative support for PV operations. This role requires strong communication skills the ability to assimilate technical information and a commitment to quality and compliance in a regulated environment.
Key responsibilities:
Enter review approve and submit individual case safety reports for assigned products
Prepare and review aggregate adverse event reports and maintain aggregate report schedules
Support risk management data acquisition and related activities
Track team metrics and maintain overview lists scheduling lists and tracking sheets
Archive PV documents (paper and electronic) in accordance with procedures
Provide administrative support for PV tasks including email triage and organization of global team group mailboxes
Support national PV teams and respond to internal requests as needed
Participate in PV projects as agreed with the manager (e.g. database upgrades training procedure management)
Support compliance metrics literature searches audit/inspection facilitation and become knowledgeable about relevant legislation
Required qualifications Education (one of the following):
Degree in Veterinary Technology/Technician OR
BA/BS or equivalent degree in a relevant field OR
Associate degree (or equivalent) with prior experience in the pharmaceutical industry
Required experience and skills:
Strong written and oral communication skills
Ability to assimilate technical information quickly and accurately
Capable of working independently and collaboratively within a team
Strong organizational skills attention to detail and punctuality in meeting deadlines
Proficiency with Microsoft Office applications (Outlook Excel PowerPoint)
Preferred qualifications:
Prior experience working in a veterinary clinic
Prior pharmacovigilance experience
At least 1 year of experience in a highly regulated pharmaceutical field
Proficiency with other software such as SharePoint learning management systems and document management systems
Experience with pharmacovigilance databases and support of system maintenance activities
Familiarity with IT concepts relevant to PV systems (e.g. report submission acknowledgments product family maintenance)
Required Skills:
Adaptability Adaptability Adverse Event Report Animal Handling Applied Engineering Clinical Trial Management Communication Complaint Management Compliance Investigations Data Analysis Data Management Detail-Oriented Drug Safety Surveillance Employee Training Learning Management Systems (LMS) Management Process Oral Communications Pharmacovigilance Pharmacy Regulation Punctuality Regulatory Communications Regulatory Compliance Risk Management Risk Reporting Software Office 2 morePreferred Skills:
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 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:
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 anothers 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 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
$85600.00 - $134800.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
10/8/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Employment Type
Full-Time
