New · posted Nov 7
Amneal Pharmaceuticals · Pharmaceuticals
Director, Pharmacovigilance & Drug Safety
- Piscataway, NJ
- On-site
- Full-time
- Director
The role
The Director, Clinical Safety and Pharmacovigilance, heads the pharmacovigilance group and is responsible for all Pharmacovigilance and Safety related activities for all Amneal products from clinical development to approval and post marketing activities. The person is responsible for oversight of compliance with standard operating procedures and activities relating to the detection, assessment, and reporting of adverse effects or any other medicine-related safety concerns. This position ensures all safety and pharmacovigilance aspects are managed in accordance with national and international regulations. The Director, Clinical Safety and Pharmacovigilance mentors' other team members on all aspects of core signal detection, safety responses, Medical Scientific Literature, Aggregate Report, Medical Assessment and Causality Assessment. The person oversees all aspect's related to safety profiles for investigational products, serving as the product safety expert, working in partnership with team members from regulatory, labelling, marketing to bring potential safety issues to the attention of the clinical team and upper management, and supporting clinical operations teams with respect to safety-related issues as required. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety programs, priorities, resources, and milestones.
What you need
Education
- Doctorate Degree MD - Required
Experience
- 10 years or more in Clinical Safety experience
Specialized Knowledge
- In-depth knowledge of clinical trial safety across the product lifecycle, including SAE assessment, causality and expectedness, reference safety information, expedited safety reporting, aggregate clinical data review, signal evaluation, benefit–risk assessment, and risk mitigation. Demonstrated hands-on experience with protocols, Investigator’s Brochures, Safety Management Plans, DSURs, clinical study reports, safety committees, and regulatory responses.
The salary range for this position ranges from $200,000 - $250,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
What you'll do
- Assess significant safety cases, review cumulative safety data, evaluate signals and benefit-risk, and recommend safety actions.
- lead medical safety oversight for assigned clinical trials and development programs, including study teams and safety governance.
- Provide medical safety input and review for study documents, safety reports, and regulatory submissions.
- Review and approve, within delegated authority, clinical safety narratives, aggregate analyses, and medical assessments supporting safety reports and regulatory submissions.
- Any other additional activity as needed
- Provide medical input into Development Safety Update Reports (DSURs), investigator brochure updates, clinical overviews, integrated safety summaries, and responses to health authority questions.
- Oversee outsourced clinical safety activities and support compliance, inspection readiness, and cross-functional coordination.
- Serve as the sponsor’s medical safety lead for interactions with Data Safety Monitoring Boards (DSMBs) and Independent Data Monitoring Committees (IDMCs), as applicable.
- Provide backup coverage for other Medical Directors across designated clinical and marketed products, within training and delegated authority.
- Support SOPs, process improvements, and risk management initiatives.
- Mentor Safety Scientists, contribute to training, and support departmental planning.
Pay and benefits
$200,000 – $250,000 a year
Employer providedShort-term incentive (bonus)
Long-term incentive (restricted stock units)
Health and insurance benefits
401(k) matching contribution
Employee well-being programs
Where you'll work
Piscataway, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Piscataway, NJJob intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in New Jersey7 roles publishing pay
Director roles in the US87 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $250,000 |
| New Jersey (middle half) | $205,500 | $225,000 | $248,750 |
| All US (middle half) | $226,000 | $263,500 | $279,250 |
This role: Amneal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 164 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Amneal's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs6
- Collaboration and leadership6
- Clinical trial conduct4
- Investigations and CAPA3
- Regulatory submissions3
- GMP and compliance2
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Safety & Pharmacovigilance work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amneal on Regulatory Jobs
- 18
- Open roles
- 18
- Distinct roles
- 3
- Locations
By discipline
- Quality18 95%
- Clinical1 5%
By level
- Associate & Specialist8 42%
- Senior & Principal7 37%
- Director2 11%
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Director, Pharmacovigilance & Drug Safety at Amneal
Open until filled. $200K–$250K a year, employer provided.