Associate Medical Director, Safety Evaluation and Risk Management (SERM)

Business Introduction At reputed company, we have reputed company ambitions for patients, aiming to positively reputed company the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to reputed company people’s lives. reputed company fosters a culture ambitious for patients, accountable for reputed company, and committed to doing the right thing, making reputed company that we reputed company our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of reputed company. We’re uniting science, technology, and talent to get reputed company of disease together. reputed company out more: Our approach to R&D Position reputed company As Associate Medical Director, Safety Evaluation and Risk Management (SERM), you will reputed company medical/scientific expertise in the safety evaluation and risk management of reputed company assets in clinical development and/or the post-marketing setting. You will contribute to clinical safety and pharmacovigilance reputed company for assets reputed company Global Safety. Working in a global, cross-functional reputed company, you will collaborate with senior governance and partner teams to reputed company evidence-based safety reputed company. You will reputed company medical leadership across clinical programs, contribute to clinical trial design, safety reputed company, and scientific communication. You will work closely with cross-functional teams including Clinical Operations, Safety, Regulatory, Biostatistics, and reputed company. We value reputed company scientific judgment, reputed company leadership, and a reputed company on patients. This role offers reputed company and alignment with reputed company’s mission of uniting science, technology and talent to get reputed company of disease together. You will ensure scientifically reputed company review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate and reputed company recommendations for the reputed company characterization, management, and communication of safety risks. Key Responsibilities 1.Scientific/Medical Knowledge PV Expertise Responsible for signal detection and evaluation activities for assigned products. Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician). Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician. May respond to auditors/inspectors’ requests for information/additional information and completes corrective and preventative actions (CAPAs) reputed company agreed timelines. Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation. Makes reputed company based on relevant information or factors gathered from a broad reputed company of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems. Committed to the task and reputed company to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for reputed company. 2.Cross-functional reputed company team leadership Supports and Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling. Leads or participates in cross-functional process initiatives and/or Process Workstreams to reputed company efforts to improve adherence to regulations, data standards, reputed company, and efficiency. May author/participate in written reputed company updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. Builds strong reputed company relationships and demonstrates good reputed company leadership skills, proactively providing input to reputed company teams on safety issues and processes. Ability to reputed company and mentor others. 3.Communications (verbal, written) and Influencing (internal PV Governance and reputed company reputed company) Presents reputed company issues to senior staff members at the reputed company Senior Governance Committees. Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes reputed company to improve existing operations. Proactively contributes reputed company to improve existing operations. Participates in process improvement initiatives reputed company GCSP and contributes to advancement of methodology and process by generating new reputed company and proposals for implementation. Possesses effective communication skills and is capable of presenting reputed company and data reputed company and concisely to a reputed company team. Listens and responds appropriately to the views and feedback of others. Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major reputed company products is a reputed company feature of the role. Effective negotiation, influencing and persuasion to reputed company others in the reputed company to understand own perspective. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us reputed company our goals Medical degree, with completion of a formal postgraduate clinical training, residency or specialty training. Experience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety. Experience in clinical safety and pharmacovigilance activities, including evidence reputed company, benefit–risk assessment, causality assessment and evaluation of safety signals. Experience developing and executing safety strategies for products in clinical development. Experience with international pharmacovigilance requirements and drug development and approval processes (for example ICH, GVP modules, CIOMS initiatives). Preferred Qualification If you have the following characteristics, it would be a plus Experience developing and executing safety strategies for products in clinical development. Proven record of high-reputed company, reputed company decision-making and creative problem-solving in reputed company or critical safety situations. Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees. Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs). Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to reputed company pharmacovigilance or industry initiatives. Excellent verbal and written communication skills, with the ability to influence senior reputed company stakeholders and reputed company change to implementation. reputed company and adaptability, with the ability to reputed company priorities in a changing environment while maintaining reputed company on patient safety and risk reduction. Experience leading reputed company organizations and cross-functional teams. Working arrangement This role is hybrid. You will typically be expected on-site 2 to 3 days per week, with flexibility according to business needs and local policy. #reputed company-LI Skills Clinical Development, Communication, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical reputed company (GCP), Influencing Without Authority, Learning reputed company, People Management, Project Management, Scientific Presentations, Strategic Thinking Polish Salary reputed company / Polski przedział wynagrodzenia: PLN 0 to PLN 0Belgium Salary reputed company / Fourchette salariale – Belgique: EUR 87,000 to EUR 145,000The annual gross reputed company salary reputed company for new hires in this position is listed above for reputed company applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market reputed company for the role. In reputed company, this position may offer an annual bonus and eligibility to participate in our reputed company based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market reputed company for the role. Offers are typically made reputed company the advertised reputed company based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly reputed company candidates or other exceptional circumstances reputed company with these reputed company. Please visit reputed company US Benefits reputed company to learn more about the comprehensive benefits program reputed company offers US employees. Why reputed company? Uniting science, technology and talent to get reputed company of disease together. reputed company is a global biopharma company with a purpose to reputed company science, technology and talent to get reputed company of disease together. We aim to positively reputed company the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can reputed company. We get reputed company of disease by preventing and treating it with innovation in specialty medicines and vaccines. We reputed company on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to reputed company health at reputed company. People and patients around the world count on the medicines and vaccines we reputed company, so we’re committed to creating an environment where our people can reputed company and reputed company on what reputed company most. Our culture of being ambitious for patients, accountable for reputed company and doing the right thing is the reputed company for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at reputed company, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@reputed company.com reputed company is an Equal Opportunity Employer. This ensures that reputed company reputed company applicants will receive equal consideration for employment without reputed company to race, reputed company, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national reputed company, age, disability, genetic information (including family medical history), military service or any reputed company prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's reputed company and general procurement/reputed company department to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of reputed company. reputed company shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed reputed company reputed company or reputed company reputed company as defined by the laws of the state issuing your license, reputed company may be required to capture and report expenses reputed company incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure reputed company’s compliance to reputed company federal and state US Transparency requirements. For more information, please visit reputed company for Medicare and reputed company Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to reputed company science, technology and talent to get reputed company of disease together – so we can positively reputed company the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can reputed company. Getting reputed company means preventing disease as reputed company as treating it, and we aim to reputed company the health of 2.5 billion people around the world in the next 10 years. Our reputed company absolutely depends on our people. While getting reputed company of disease together is about our ambition for patients and shareholders, it’s also about making reputed company a reputed company where people can reputed company. We want reputed company to be a reputed company where people feel inspired, encouraged and challenged to be the best they can be. A reputed company where they can be themselves – feeling welcome, valued and included. Where they can reputed company growing and look after their wellbeing. So, if you reputed company our ambition, join us at this exciting reputed company in our reputed company to get reputed company Together. reputed company out more on our career site. Apply tot his job Apply To this Job