Associate Director, Medical Affairs
Apellis Pharmaceuticals
Associate Scientific Director, SERM
GSK
full-time
Posted on:
Location Type: Hybrid
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
Lead
About the role
- Provide medical/scientific expertise in the safety evaluation and risk management of assigned GSK post-marketing and late-stage clinical assets
- Detect and evaluate safety signals for assigned products
- Drive production of regulatory periodic reports, associated documentation and RMPs globally; advise on content in partnership with product physicians
- Escalate safety issues identified through the safety review process to senior management and safety governance as appropriate
- Make recommendations for further characterization, management, and communication of safety risks
- Support pharmacovigilance and benefit-risk management of the assigned portfolio to ensure patient safety globally
- Support and facilitate safety governance/SRTs by assisting in establishment and operation of cross-functional teams
- Ensure risk-reduction strategies are implemented in clinical study protocols and/or product labelling
- Build strong collaborative relationships across matrix teams; coach and mentor colleagues
- Prioritise activities effectively to meet multiple deadlines with attention to detail
Requirements
- Health Sciences/Health Care Professional degree (or equivalent) required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D)
- Advanced degree preferred
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes
- Experience working in large matrix organisations
- Robust medical/scientific writing skills
- Ability to coach and mentor others and demonstrate matrix leadership
- Effective communication skills and ability to present to senior staff and governance committees
Benefits
- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Hybrid working model via Performance with Choice programme
- Agile working practices and flexibility
- Recruitment adjustments support (contact provided)
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancesafety evaluationrisk managementmedical writingclinical developmentpost-marketing activitiesregulatory periodic reportsrisk-reduction strategiesdrug development processesinternational pharmacovigilance requirements
Soft skills
coachingmentoringcollaborationcommunicationattention to detailprioritizationmatrix leadership
Certifications
Health Sciences degreeBScMSPhDRNBSNMSNNPRPhPharm D
