Global Safety Leader Ch

1 week ago

Reading, United Kingdom Bayer Full time

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Global Safety Leader CH**

**Global Safety Leader**

**Major Tasks**:

- Review emerging safety data from various sources (e.g. literature, studies, safety database)
- Identify, validate, prioritize, and analyze clinical safety signals within company / regulatory timelines and ensure appropriate clinical safety risk communication and escalation within Safety Committees, as required.
- Compilation and timely delivery of aggregate reports (PSUR/PBRERs, DSURs, RMPs) and benefit-bisk assessments and statements, safety section of dossiers, justification documents, etc.
- Provide timely and high-quality responses to safety relevant Health Authority requests and questions
- Develop safety relevant communications such as DHCP letters and company statements
- Ensure adequate labelling of safety related information according to respective guidance and rules for OTC drugs and other consumer/self-care products
- Collaborate closely with relevant internal stakeholders (e.g., Medical, Regulatory, Labelling, Business Units etc.)
- Provide high quality input / safety strategy into Due Diligences, New Product Developments, Roll out plans, Consumer Health studies (clinical/observational/sensory) and life-cycle management activities
- Interact with license partners regarding agreed pharmacovigilance activities

**Position**:
**Skills**:

- Significant experience in the pharmaceutical industry or consumer health industry in scientific function(s), e.g. pharmacovigilance, medical affairs, clinical development
- Technical expertise in pharmacovigilance and clinical safety/signal management
- Experience with OTC (over-the-counter)/monograph medication preferred
- Ability to lead and perform in-depth analysis of complex and multivariate safety data using incisive problem-solving skills. Develop conclusions and lead solutions with an empowered and ownership-based mindset.
- Pharmacoepidemiology skills welcome
- Professional level English, both written and verbal
- Proven evidence of effective delivery / review of high-quality safety relevant documents.
- Excellent communication and presentation skills both verbally and in writing
- Strong presentation skills. Effective at summarizing and key considerations and decision points
- Strong influencing skills to explain and defend a position in the face of opposition.
- Strategic focus on safety activities, with proactive planning and prioritization skills.
- Appropriate experience with Regulatory Agencies, good knowledge of pharmacovigilance relevant regulations and especially OTC standards.
- Strong scientific and business acumen.
- Rx-to-OTC Switch safety experience a strong plus
- Strong leadership and interpersonal skills with refined ability to collaborate and negotiate in cross-functional, global teams.
- Ability to work with and influence all levels of an organization.
- Empowered to challenge behaviors and mindsets to introduce and model efficient and smart ways of working to drive efficiency and collaboration.

**Location**:
United Kingdom : Berkshire : Reading || United Kingdom : Cambridgeshire : Cambridge

**Division**:
Pharmaceuticals

**Reference Code**:
789434

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