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International Drug Safety Manager - Bayer HealthCare Pharmaceuticals
Sep 18
Location: Pine Brook , NJCategories: Pharmaceutical
Website: http://bayerjobs.com
Position Description
At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women’s Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.
The International Drug Safety Manager (IDSM) is a global role within the Pharmacovigilance Assessment of Global Pharamcovigilance (GPV) . The IDSM leads the GPV activities in the approval of SAE reports, the production of summaries of data (PSRs and PSURs) and the management of the overall safety profile of allocated products. This role is to support products within the Primary Care portfolio, with a focus on development and marketed anti-microbial agents.
In a self-managed manner the IDSM assures high quality medical review of cases and consistent case assessment on a global level for an assigned portfolio. Is responsible for high quality aggregate reports (e.g. PSURs, ASRs and Safety Risk Management Plans as applicable) and submits results along with conclusions and recommendations to supervisors. Reviews, finalizes and distributes drug safety and pharmacovigilance information in assigned therapeutic areas for investigational and marketed drugs, ensuring highest quality, accuracy and timeliness with respect to Bayer SOPs and global regulatory guidelines and in cooperation with other central and local functions such as DST, DSS, Head PV Assessment, Head of Systems and Operations and Head Global Pharmacovigilance. Identifies and evaluates potential safety signals and develops strategies and measures to prevent risks including a risk management plan, when applicable.
The position requires incisive problem-solving skills to perform in-depth analysis of complex and multivariate safety issues and then clear presentation skills to provide analysis and strategic leadership to Bayer management, domestic and international peers, subordinates, clinical investigators, medical affairs personnel, internal and external legal counsel, international safety and regulatory officers, as well as Quality Assurance, Marketing, Sales and Manufacturing personnel. Critical and timely insight are key vigilance determinants to assure public safety.
Incumbent must have an advanced degree (Dr., MD, PhD, DVM, or PharmD) in a life-science discipline with a minimum of seven years experience in the pharmaceutical industry (or equivalent), or M.S./M.A. in one of the life sciences (or professional certification/license in a health care profession, or equivalent professional experience) with a minimum of ten years of pharmaceutical industry experience (or equivalent).A minimum of six years of drug safety experience (either in a drug safety department or equivalent clinical setting) is required.
Must have in-depth knowledge and analytical skills in at least two therapeutic areas where Bayer drug products are marketed or in development. The incumbent will have demonstrated proficiency in problem-solving with respect to pharmaceutical safety issues. Must be expert in international regulations governing drug safety reporting and capable of managing compliance with pertinent global and domestic regulatory requirements. It is desirable that the incumbent be familiar with ethical-legal aspects of drug safety and capable of assisting Bayer corporate counsel in litigation involving Bayer ethical pharmaceuticals.
Must be knowledgeable with regard to computer techniques, particularly global safety database systems operation and management. The incumbent must be capable of exercising oversight in communications and problem solving liaisons with internal customers in Bayer Medical Affairs, Regulatory, Legal, and Sales/Marketing, as well as Global Pharmacovigilance personnel in all issues affecting assigned product responsibilities.
The incumbent must have excellent verbal and written communication skills with a preference for candidates with experience working in a global environment.
Must be capable of exercising oversight in the maintenance of currency among Global Pharmacovigilance personnel in the field of pharmaceutical drug safety and pharmacovigilance. It is desirable that the incumbent be capable of directing the participation of safety personnel in workshops, seminars, courses, literature, or other means consistent with Global Pharmacovigilance Safety Group development and objectives set by his supervisors.
Personal attributes and skills:
· Likes to work on own initiative
· Likes to work on own responsibility
· Understand , when there is a need to escalate and how to prepare decisions
· Understands team work and like to actively transfer know-how to other team members
Addresses problems in a constructive way by proposing potential solutions
As a member of the Bayer HealthCare Pharmaceuticals team, you’ll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues.
