Job Title: Associate Manager, Safety Medical Writing
Location: SAS Nagar (Mohali), India
Additional Locations: India-Bengaluru; India-Hyderabad-Mindspace 20
Job Purpose:
The Associate Manager, Safety Services (SS) will oversee the operations of aggregate and allied safety report writing, CSR narratives, and signal detection activities. This role includes managing resources, ensuring quality, providing leadership in projects, and contributing to strategic and client-focused initiatives. Line management responsibilities and subject matter expertise are integral to this role.
Key Responsibilities:
Line & General Management:
Lead and mentor safety writing staff including recruitment, training, performance evaluations, and team morale.
Oversee quality compliance and ensure optimal billable hours.
Manage underperformance through coaching or formal action plans.
Client Liaison:
Understand and meet client expectations.
Build strong client relationships and address any concerns.
Support proposal development with scope assessments and attend client meetings as needed.
Project Management:
Set clear objectives and monitor team performance.
Communicate project expectations and maintain timeline awareness.
Propose solutions for resource and timeline challenges.
Ensure team learning from each project experience.
Authoring & Technical Expertise:
Independently prepare and finalize high-quality aggregate safety reports or CSR narratives.
Stay updated on global regulatory guidelines (ICH, GVP, FDA, EMA) and apply insights to deliverables.
Signal Detection & Management (If applicable):
Perform signal detection using regulatory and internal databases.
Lead the end-to-end signal management process including assessments and presentations.
Quality Control:
Ensure timely, quality deliverables aligned with client and regulatory standards.
Lead technical quality checks and align with SOPs.
Training & Compliance:
Stay informed of regulatory changes and industry trends.
Deliver training sessions and mentor SS team members.
General Contributions:
Support management in absence of leads.
Take on additional responsibilities appropriate to the seniority level.
Skills Required:
Excellent interpersonal and communication abilities.
Strong leadership, problem-solving, and decision-making skills.
High adaptability, time management, and organizational capability.
Ability to handle confidential matters and operate under pressure.
Advanced MS Office skills, particularly in Word and Excel.
Knowledge of IT systems like SharePoint and document management tools.
Knowledge & Experience:
Proven experience in pharmacovigilance and safety report writing.
In-depth understanding of drug development and regulatory frameworks.
Project management and client-facing experience is a plus.
Business awareness and ability to support business development.
Education:
A degree in Life Sciences, Pharmacy, Medicine, or a related field.
Additional qualifications in Medicine, Dentistry, Physiotherapy, or Nursing with clinical exposure will be an advantage.
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