Senior Specialist, Drug Safety (Hybrid)

Job Description

Develop and maintain the necessary processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations. Maintain knowledge of PV regulations related to drugs, vaccines, biologics and devices. Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.

• Lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual adverse experience case and periodic reports.
• Provide expert guidance and perform safety system configuration update and maintenance activities to ensure compliant case data handling as part of the end-to-end Individual Case Safety Report (ICSR) lifecycle: Study Configuration, Product Configuration, Reporting Destinations, Reportability Rules and Label Validation Files.
• Support Safety System Development Lifecycle (SDLC) activities to ensure these systems remain compliant with both internal and external requirements and pursue process efficiencies.
• Provide content for the ongoing development and expert review of the Global Safety Database User Manual, Standard Operating Procedures, and training material as needed to ensure accuracy.
• Provide expert guidance on the PV activities outlined by procedures (SOPs, User Manual, etc.).
• Responsible for drafting, negotiation, and maintenance of PV agreements and safety management plans.
• Identify and prioritize PV agreements and safety management plans to maintain compliance with worldwide regulatory requirements.
• Responsible for the end-to end GCS&PV implementation and maintenance for select business deals.
• Support due diligence and qualification activities for select partner deals/projects.
• Interact closely with the business system owner for the maintenance of the Business Development Lifecycle Management system.
• Perform quality review of expedited and periodic reports to ensure adherence to global case processing standards and regulatory requirements.
• Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.
• Lead efforts to improve departmental efficiencies and continuous improvement.
• Process incoming communications from internal and external sources and initiate appropriate course of action and/or response.
• Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.
• Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.
• Follow company polices and legal guidelines at all times.
• Develop and support processes that facilitate achievement of GCS&PV objectives.
• Support any other project or perform any other task deemed appropriate by management.

Qualifications, Skills, and Experience

Education:

• Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field.

Required:

• Candidate is required to have at least two years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory.

Preferred:

• Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible to meet daily competing priorities of the business.
• Demonstrates leadership, and excellent communication and interpersonal skills.
• Ability to manage and independently drive projects to completion.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Requisition ID:R251950