Associate Director, Drug Safety

Job title:

Associate Director, Drug Safety

Company

MSD

Job description

Job DescriptionLead and develops the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and devices and provide expert guidance. Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.Ensure that PV activities are supported by robust procedures (e.g., SOPs, User manuals, etc.).Promote understanding and education of PV regulation with all of company’s business units to ensure compliance and patient safety.Assist in the development and leadership of team members.Develop and implement strategies aiming to promote the mission and vision of organization.Lead core activities tied to individual adverse experience cases and periodic reports to ensure standardization and optimization from both a system and process prospective.Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.Lead efforts to improve departmental efficiencies.Monitor metrics are tracked to demonstrate compliance with PV regulation and timelines.Collaborate with and maintain effective working relationships with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports.Collaborate closely with IT and engage members from the business to implement system improvements and updates of safety database.Provide expert guidance on policies and procedures related to quality and compliance of expedited and periodic reports.Interpret FDA and EU regulations and ICH guidelines to ensure compliance globally.Ensure company polices and legal guidelines are followed 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.Education:Bachelor’s degree or master’s degree in health care/pharmaceutical related field or project managementRequired:Candidate is required to have five years of safety experience or related areas such as Clinical Risk Management, Clinical or RegulatoryPreferred:Strong knowledge base of pharmacovigilance regulations and can function with a high degree of autonomyAbility to engage cross-functional stakeholders both internal and external to our companyAbility to identify potential compliance gaps and quickly develop solutionsDetail-oriented individual who enjoys analyzing and comprehending complex documents, along with possessing proficient writing skills.NOTICE FOR INTERNAL APPLICANTSIn accordance with 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 applyCurrent Contingent Workers applyUS 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 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: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.U.S. Hybrid Work ModelEffective 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, generally Tuesday, Wednesday and either Monday or 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: $122,800.00 – $193,300.00Available 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 .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: No Travel RequiredFlexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 09/20/2024*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.

Expected salary

Location

Gwynedd, PA – Wales

Job date

Wed, 11 Sep 2024 03:38:48 GMT

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