Bayer

Associate Director Product Quality Safety Consumer Health

Employer
Bayer
Location
Whippany, NJ, United States
Posted
Jun 01, 2018
Ref
SF22189
Required Education
Bachelors Degree
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Associate Director Product Quality Safety Consumer Health, are to:

  • Be responsible for timely provision of quality-safety assessment of Consumer Health (CH) product related product technical complaint and adverse event (PTC+AE) reports including entry of cross-reference of global case IDs, as well as quality-safety assessments for medical device complaints in the global complaint / safety database; interaction with Pharmacovigilance (PV) internal and external partners for clarification and follow-up, including cooperation with PV Case Processing (Triage, Case Evaluators), Global Safety Leaders (GSLs), Pharmacovigilance Country Heads (PVCHs), and the local and global quality units (Country Quality Functions (CQFs), responsible quality units (RQUs), divisional quality assurance (QAs));
  • Set-up and conduct or supervision of complaint, product technical complain (PTC), quality issue, and usability issue related retrievals from the global complaint database, PV database, global sales database, and others as appropriate;
  • Perform review of medical device complaints, drug product PTCs/PTC+AEs, lack of drug effect (LODE), and usability issues for potential signals including batch related signals; interacts with global (GSLs, RQUs, divisional QAs) and local responsible PVCHs, LQRs) in the context of signal management and assessment of potential medical impact, and reports to PV PQS Gatekeeper for escalation into complaint review meetings or gatekeeper review, on request;
  • Retrieve and review complaints, PTC, LODE, and usability related data and performs safety related evaluations in collaboration with GSLs and RQUs for complaint reviews, customer feedback, periodic safety update reports(PSURs)/periodic benefit risk evaluation reports (PBRERs), safety risk management plans (SRMPs), as well as for audits and inspections on request;
  • Cooperate with PV internal and external partners on PTC and usability issue handling and related questions, technical / complaint error types and potential causal relationship to adverse events; keeps a PTC related process oversight, identifies improvement needs, and drives corrective actions as well as continuous process improvement;
  • Be an expert in PV on quality related aspects with potential impact on product safety such as subvisible particles, particulate matter in parenterals, and leachables, medical device related aspects such as usability issues, and design control, pharmaceutical production related matters such as manufacturing procedures, galenical formulation of drug product, container closure systems, analytical methods in product release and stability studies, quality assurance procedures including batch record review, deviation handling, and investigation of out of specification test results;
  • Be an expert in PV on CH medical device complaint handling including vigilance and post-market surveillance, and supports PV internal and external partners in these matters and respective responsibilities on request;
  • Give input to Quality System Documents;
  • Support and provide training in PV regarding handling of complaints/PTCs and product specifics such as error types and associated safety risks;
  • Support PV product quality safety (PQS) Gatekeeper for Product Quality Safety Committee topics as well as audits and inspections for preparation, conduction and post-activities, supports projects and report compilation for qualifed person for pharmacovigilence (QPPV);
  • Act as a liaison to facilitate and lead routine PV/QA partnership group meetings and actively ensure process compliance, provide expert direction such as identify deficiencies, route cause identification, calibration discussions, and training, and drive process optimizations as it relates to PTC/PTC+AE, case handling and other related matters for all CH products;
  • Construct and deliver presentation proposals to internal and external stakeholders, including recommendations for process modifications, trainings, and optimization based on PV/QA partnership group meeting outcomes such as CH Marketing functions;
  • Support over the counter (OTC) packaging and formulation quality / safety recommendations, child-resistant container (CTC) packaging safety recommendations;
  • Support new product development (NPD) projects concerning product quality safety.


Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Bachelor's degree with four years of professional experience in Pharmaceutical Production, Quality Control, and/or Quality Management/Quality; Assurance, Pharmacovigilance, or similar supportive function;
  • Good basic medical, pharmacological, and statistical knowledge;
  • Good basic knowledge of Global PV database and metrics;
  • Good knowledge in major pharmacopeias (PharmEur., United States Pharmacopeia (USP)), monographs, and compendial methods;
  • Knowledge of current good manufacuring practices / current good laboratory practices (cGMP/cGLP), regulatory, Pharmacovigilance requirements, and drug development process;
  • Very good skills in project management;
  • Proficiency/experience with the use of MS Word, MS Excel, MS PowerPoint;
  • English fluent in written and spoken;
  • Experience in project related work;
  • High degree of responsibility and self-independent working;
  • Accurateness, precise, and keeping discretion;
  • Reliability, keep timelines and standards;
  • Proactive and initiative-taking attitude;
  • Systematic and efficient way of working;
  • Cooperative team skills;
  • Ability to work cross-functionally in a global environment;
  • Good organizational and communicational skills;
  • Ability to work flexible hours (if required).


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Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States
Location: NJ-Whippany