Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Pharmacovigilance

Expired Job

Amicus Therapeutics, Inc. Cranbury , NJ 08570

Posted 3 months ago

Associate Director, Pharmacovigilance Position Summary

Provide medical review and assessment of individual case safety reports created by a pharmacovigilance vendor. This includes review for seriousness, expectedness and AE coding, creation of follow up questions for each case. Requires minimum of three years concentrated experience with medical review and assessment. The Safety Physician will lead surveillance responsibilities, including interpretation and evaluation of aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations.

Roles and Responsibilities

  • Oversees the provision of medical assessments of product complaints and of all clinical and post-marketing adverse event case reports by CROs or business partners.

  • Execute the medical review of clinical trial SAE reports and all post-marketing

  • reports (narrative, coding, expectedness, causality, and company comment)

  • Provide medical queries for SAEs

  • Performs signal detection activities on adverse event data for all Amicus products in clinical development and Amicus marketed products and in consultation with the QPPV for products in territories outside the US;

  • Participates in the selection, implementation and maintenance of signal detection systems as needed;

  • Manages the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the risk management plans of marketed products.

  • Participates in the Safety Committee in maintenance of benefit risk profile of products in development and marketed products; responsible for the safety sections of Company Core Data Sheets (CCDS) and contributes to the safety sections of investigator brochures (IB).

  • Participates in labelling committees

  • Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.

  • Manages adverse event coding using MedDRA including synonym maintenance in collaboration with Corporate Drug Safety Operations.

  • Reviews aggregate reports (PADERs, PSURs, PBRERs, DSURs);

  • Prepares, implements and maintains standard operating procedures (SOPs) and policies relating to pharmacovigilance (PV) and risk management to ensure compliance with regulatory requirements;

  • Develops and conducts training as necessary.

  • Participates in internal and external audits.

  • Responsible for assisting with remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits.

Requirements

  • M.D Degree

  • Minimum of 3-5 years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations

Experience and Skills

  • Expert knowledge of FDA regulations, GVP in the EU, ICH guidelines, and other applicable regulatory guidance documents required

  • Experience with pharmacovigilance audit process. Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology preferred

  • Familiarity with common adverse event management databases (e.g. Argus) is preferred Knowledge of MedDRA and WHO Drug coding dictionaries preferred

  • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting required

  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way required

  • Comprehensive experience with obtaining, analyzing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports, is required

  • Excellent verbal and written communication skills, including formal presentations. Must have excellent written and oral communication skills, resourcefulness and personal organization skills. Proficiency in Microsoft Excel, PowerPoint and Word required

  • Sound organizational skills with the ability to prioritize tasks required

  • Excellent interpersonal, team management and leadership skills required

Travel

  • 0-5%
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Director External Corporate Communications

Amicus Therapeutics, Inc.

Posted 2 weeks ago

VIEW JOBS 10/4/2018 12:00:00 AM 2019-01-02T00:00 Associate Director - Director, External Corporate Communications Position Summary Reports to the Vice President of Investor Relations and Corporate Communications. Support the development and execution of the organization's external PR and corporate communications strategies to further solidify Amicus' reputation as a patient-dedicated rare disease company among key external stakeholders. Align external communications with IR, Human Resources, Patient Advocacy, Global Marketing, Program, Clin/Reg, Corporate Affairs and the broader Executive Team to foster and express our strategy and values through all external communications. Ensure a consistent Amicus "look and feel" to all corporate materials that reflect our patient focus and our core values. Execute and manage the implementation of the visual, verbal, and written messaging and ensure branding consistency across external outlets. Assist in the global alignment of investor relations and external communications to ensure unified messaging, and brand development. Support an overarching strategy and plan to elevate the Amicus brand. Roles and Responsibilities The Associate Director - Director, External Corporate Communications is responsible for: * Under the corporate communications strategy to build and reinforce the Amicus brand and corporate reputation, partner cross-functionally and globally to support external communications surrounding our corporate vision, company mission, and other corporate initiatives * Support development of media strategies and foster relationships with reporters to elevate the Amicus reputation and generate coverage for key corporate milestones and events. * Collaborate across departments and international geographies to ensure that a consistent corporate image is presented to media, communications outlets, analysts, investors, and all external parties. * Maintain suite of external messages and FAQs related to corporate, product and pipeline messages and coordinate with Corporate Affairs to share updates across departments and geographies * Serve as internal lead for aggregating and identifying executive profiling opportunities that enhance the Amicus reputation as thought leader in rare diseases * Work closely with Investor Relations and the Controllers department on materials such as press releases, earnings releases, presentations, and SEC filings, including content for the annual and quarterly reports. * Provide external messaging data to Corporate Affairs team to support the drafting of internal communications * Liaise with Patient Advocacy to make their materials accessible through Amicus social and digital channels * Liaise with Human Resources to support external recruitment strategies * Ensure alignment of corporate and product brand messaging by partnering closely with global marketing and brand teams * Collaborate with international team to ensure alignment of global and international brand, as well as consistency across corporate materials provided to local teams. * Establish and maintain brand guidelines and turnkey materials for local customization by international markets * Work with international communications team and country-level markets to ensure consistent implementation of corporate brand, materials and narrative * Maintain suite of talking points, messages and FAQs for designated spokespersons * Gather and incorporate feedback from local markets in development of new corporate materials * Digital Communications / Traditional and Social Media * Support development of media strategies and engage and obtain coverage from reporters and news outlets, including top-tier, trade and medical journals * Serve as internal lead for corporate website content creation and related assets, as well as architectural updates and site navigation driven by analytics. * Oversee creation of corporate assets including videos, brochures and other written promotional materials, social media. * Expand social media and other media avenues to support the corporate brand/reputation, including build out of our video and materials library and to incorporate more international content into the global social media feeds. * Partner across functions to support e-recruitment strategies and ad campaigns, study branding and brochures/materials for clinical studies * Partner across functions to gather broader content for social media to highlight our corporate vision and overall culture. * Project Management (Daily) * Manage utilization of external PR agencies on corporate communications and media relations strategies to ensure timely completion of projects and adherence to quality and brand guidelines. * Collaborate with digital design firms/agencies on creative concepts and to ensure uniform look/feel, global brand integrity, and timely completion of project Requirements * Bachelor's degree or higher Experience and Skills * Bachelor's degree and a minimum of 8 years of experience working in Corporate Communications and Public Relations in a biotech/pharmaceutical company and/or in an agency setting. * Demonstrated track record of conducting successful, proactive global communications programs across channels * Ability to provide strategic communications counsel to senior management * Excellent personal relationships with healthcare reporters & industry media * Ensures strategic plans are fully implemented and high quality global communications materials are produced in a timely manner * Strong understanding of the biotech/rare disease early stage, development and commercial business * Ability to lead communications during crises, issues and industry affairs * Superior writing, editing, and proofreading skills as well as ability to source stories * Communicates technical information in a digestible manner across a variety of audiences and channels * Digital expertise with social media and digital channels * Strong interpersonal skills, personal organization and integrity * Natural fit with Amicus beliefs and patient-dedicated culture Travel * Travel Requirements: 10%-20% Amicus Therapeutics, Inc. Cranbury NJ

Associate Director, Pharmacovigilance

Expired Job

Amicus Therapeutics, Inc.