Global Safety Leader for Pharmacovigilance Risk Management (m/f)


Tue, 27 Dec 2016 17:45:59 GMT


Your tasks and responsibilities • Lead the Pharmacovigilance (PV) Risk Management processes for assigned portfolio in Women's Healthcare Therapeutic Area • Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with Bayer and PV processes • Identify, prioritize and analyze clinical safety signals • Perform ongoing review of emerging safety data from various sources including single case reports, product technical complaints (PTCs), published literature and reports from partner functions • Cooperate with systems and operations teams to develop, continuously maintain and improve effective systems to ensure single cases (incl. PTCs and other relevant reports) fulfill the requirements for signal detection and aggregate report compilation through targeted training • Ensure appropriate clinical safety risk communication and escalation within Bayer to PV Management, QPPV, Bayer Safety Committees and Medical Governance Committees • Ensure effective and timely delivery of: - Aggregate reports and risk management plans - Benefit Risk Statements - Answers to assigned safety relevant Health Authority (HA) requests and complex A2Qs - Safety relevant communications such as DHCP letters and company statements • Liaise with internal and external experts /thought leaders to obtain specialized medical expertise as appropriate • Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management • Provide medical safety oversight of clinical study data in the context of the medical review process for clinical studies

Who you are • Medical doctor's degree or equivalent • Several years of clinical and/or industry experience, with a focus on patient safety or prior pharmacovigilance experience preferred • Good knowledge of pharmacovigilance relevant regulations • Proven evidence of effective delivery of high quality safety relevant documents • Initial experience with interactions with major Regulatory Agency • Knowledge of relevant concepts in epidemiology and statistics • Knowledge of the Women’s Healthcare TA is advantageous but not required • Strong analytical and problem solving skills • Excellent interpersonal and communication skills • Ability to provide effective and relevant review of complex documents along with the competency to communicate complex issues in an understandable, effective and relevant manner and to explain and defend a position in the face of opposition • Fluent in English, both orally and in writing

Your application We offer a competitive salary in an international environment as well as excellent opportunities for professional and personal development. If your background and personal experience fit this profile, please send us your complete application at, submitting a cover letter, your CV and references as well as your salary expectations.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht. Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.

Country: Germany
Location: Berlin
Reference Code: 0000183935

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