Associate Director

Tucker Parker Smith Group (TPS Group); Brisbane (CA); On-site; USD 200,000 - 270,400; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading pharmaceutical company specialized in therapeutics is seeking an Associate Director of Safety Science. The position involves thorough medical reviews of safety data, evaluating safety signals, and preparing regulatory documents. Candidates should possess strong safety surveillance knowledge and an advanced degree in a relevant field. The role offers competitive pay at $130/hr with a 12-month assignment potential to extend.

Qualifications

• Strong knowledge of safety surveillance and regulatory reporting.
• Experience with safety databases (e.g., Argus).
• Familiarity with global safety regulations and MedDRA coding.

Responsibilities

• Conduct thorough medical reviews of ICSRs.
• Ensure proper MedDRA coding and evaluation of safety signals.
• Contribute to regulatory documents like 15-day Alert Reports.

Skills

Safety surveillance knowledge

Safety databases (e.g., Argus)

Global safety regulations

Data communication skills

Education

Advanced degree (MD, PharmD, PhD)

Tools

Safety data software

Job description

1 day ago Be among the first 25 applicants

Direct message the job poster from Tucker Parker Smith Group (TPS Group)

Department: Pharmacovigilance / Drug Safety

Reports To: Director or Senior Director, Safety Science

12 Month Assignment (Potential to Extend)

Pay Rate: $130/hr.

On behalf of our client a leading pharmaceutical company specialized in therapeutics for patients dealing with life threatening rare genetic diseases. The Associate Director of Safety Science is responsible for the medical review and analysis of safety data for the company’s products. This includes reviewing individual case safety reports (ICSRs), detecting and evaluating safety signals, preparing safety documents and aggregate reports, and working cross-functionally to support regulatory submissions and risk management activities.

Key Responsibilities:

• Conduct thorough medical review of both pre- and post-marketing ICSRs.
• Ensure accuracy in MedDRA coding and proper assessment of seriousness, expectedness, causality, and regulatory requirements.
• Identify, evaluate, and track safety signals in collaboration with Clinical Science, Medical Affairs, and other stakeholders.
• Complete quarterly signal evaluations and detailed signal work-ups.
• Contribute to the creation of key regulatory documents including: 15-day Alert Reports, SUSARs, PSURs (PBRER format), PADERs, DSURs, IND Annual Reports.
• Serve as a member of the Safety Management Team.
• Partner with Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, CROs, and Data Monitoring Committees.
• Prepare and present slide decks for internal safety review meetings.
• Assist in the preparation and review of: Investigator brochures, Clinical study protocols, Informed consent forms, Statistical analysis plans, Clinical study reports, NDA/BLA/CTD submissions, Product labeling and Risk Management Plans (RMPs).
• Work with external partners under safety data exchange agreements.
• Ensure adherence to regulatory guidelines and internal SOPs.

Required Skills & Experience:

• Strong knowledge of safety surveillance and regulatory reporting
• Experience with safety databases (e.g., Argus)
• Familiarity with global safety regulations and MedDRA coding
• Ability to work across functional teams and communicate complex data clearly

Preferred Qualifications:

• Advanced degree (MD, PharmD, PhD) in medicine, pharmacy, or life sciences
• Experience in pharmacovigilance or drug safety in the biotech or pharmaceutical industry
• Proficiency in statistical analysis and safety data interpretation

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Tucker Parker Smith Group (TPS Group) by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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