At a Glance
- Tasks: Lead safety evaluations and risk management for GSK's innovative products.
- Company: Join a global leader in pharmaceuticals dedicated to patient safety.
- Benefits: Competitive salary, bonuses, health insurance, retirement plans, and generous leave policies.
- Other info: Collaborative environment with opportunities for leadership and professional growth.
- Why this job: Make a real impact on global health by ensuring drug safety and efficacy.
- Qualifications: PharmD/PhD preferred; 5+ years in pharmacovigilance or drug safety required.
About the Role
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post‑marketing setting.
Ensures scientifically sound 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.
Makes recommendations for further characterization, management, and communication of safety risks.
Focuses on efficiency and effectiveness to meet the needs of patients and healthcare professionals.
Supports the pharmacovigilance and benefit‑risk management of the assigned portfolio of GSK global assets to ensure patient safety worldwide.
Key Responsibilities
- Scientific/Medical Knowledge PV Expertise
- Leads pharmacovigilance and risk management planning and develops strategy for evaluation of issues in the clinical matrix.
- Leads the safety component of global regulatory submissions.
- Performs expert evaluation and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
- Demonstrates quality decision making and creative problem resolution based on assessment of all supporting and conflicting information.
- Manages multi‑tasking, prioritises tasks and consistently delivers on deadlines with high quality standards.
- Explores alternatives to reach mutually beneficial agreements and solutions.
- Cross‑functional Matrix Team Leadership
- Leads safety governance by developing safety strategy and its execution for products in clinical development and post‑marketing settings.
- Facilitates safety governance/SRTs in clinical development and post‑marketing settings, assisting in the establishment and operation of cross‑functional teams to detect and address product safety issues.
- Represents GSK on cross‑functional clinical matrix teams and leads ad‑hoc teams to address urgent product safety issues.
- Leads or participates in cross‑functional process initiatives to improve adherence to regulations, data standards, quality and efficiency.
- Authors and participates in written standard updates (e. g., SOPs) to ensure policy and regulatory adherence.
- Accounts for escalation of issues and communication on safety matters.
- Builds strong working relationships and displays excellent leadership skills on safety issues, coaching and mentoring others.
- Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Leads presentations on recommendations or safety issues to senior staff members and senior governance committees.
- Represents GSK in safety‑related discussions with regulatory authorities, external consultants and partner companies.
- Leads cross‑functional process improvement teams within GSK.
- Thinks tactically and strategically, considering internal and external environments when addressing safety issues and process changes.
- Contributes innovative ideas to improve operations.
- Leads inspection readiness and supports audits/inspections.
- Exhibits excellent communication and influencing skills.
- Basic Qualifications
- Pharm D/Ph D for Scientist (preferred) or Bachelor of Science in Life Sciences or Medical Sciences (minimum).
- Advanced experience (5+ years) in the pharmaceutical or biotech industry working in pharmacovigilance or drug safety.
- Significant pharmacovigilance experience in safety evaluation and risk management, encompassing clinical development and post‑marketing activities.
- Experience with signal detection and safety surveillance.
- Knowledge of international pharmacovigilance requirements (e. g., ICH, GVP, CIOMS) and drug development and approval processes.
- Experience working in large matrix organizations.
- Previous management experience (preferred, if for team lead role).
Skills
Digital fluency, enterprise leadership, influencing without authority, pharmacovigilance, presentation techniques.
Compensation & Benefits
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $169,950 to $283,250.
The position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program.
Benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
EEO Statement
GSK is an Equal Opportunity Employer.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr
Serm Scientific Director in North East employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
StudySmarter Expert Advice🤫
We think this is how you could land Serm Scientific Director in North East
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Gsk. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Gsk.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Gsk. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Gsk is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Serm Scientific Director in North East
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Gsk!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Gsk that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Gsk!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Gsk, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Gsk
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Gsk that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Gsk’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
